Picosat II SP02 Pulse Oximetry Module and M3001A Multi-Measurement Server
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K033715 FDA 510(k)
- FDA Product Code
- DQA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2700 FDA 510(k)
- Regulation Number
- 870.2700 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Picosat II SP02 Pulse Oximetry Module and M3001A Multi-Measurement Server is a pulse oximetry device designed for non-invasive monitoring of oxygen saturation (SpO₂) in blood. It integrates with a host system to provide real-time measurements of oxygen levels, supporting clinical assessments in patient care. The device operates as part of a multi-measurement server, enabling simultaneous monitoring of additional vital signs. Its classification aligns with pulse oximetry systems intended for cardiovascular applications.
This system is supplied as a modular component, intended for integration into existing patient monitoring platforms. The Picosat II SP02 module is reusable and requires proper calibration and maintenance as specified by the manufacturer. The M3001A Multi-Measurement Server serves as the central processing unit, aggregating data from connected modules. The device holds FDA 510(k) clearance under classification DQA, with a special review designation under the Cardiovascular advisory committee. No specific sterility or MRI safety information is provided in the available data.
Frequently asked questions
What is the Picosat II SP02 Pulse Oximetry Module with M3001A Multi-Measurement Server used for?
This device is designed for non-invasive monitoring of blood oxygen saturation (SpO₂) in patients. It integrates with a host system and the M3001A Multi-Measurement Server to provide real-time SpO₂ measurements, enabling clinicians to assess cardiovascular health and patient oxygen levels during care. The modular setup also allows simultaneous monitoring of additional vital signs, enhancing comprehensive patient observation.
How is the Picosat II SP02 module supplied and is it reusable?
The Picosat II SP02 Pulse Oximetry Module is supplied as a modular component intended for integration into existing patient monitoring platforms. Unlike single-use devices, this module is reusable, provided it undergoes proper calibration and maintenance as outlined by Philips Medical Systems. The M3001A Multi-Measurement Server acts as the central processing unit, aggregating data from connected modules like the SP02.
Does the Picosat II SP02 require any special handling for sterility?
The available data does not specify any sterility requirements or procedures for the Picosat II SP02 Pulse Oximetry Module or the M3001A Multi-Measurement Server. Since it is a reusable device intended for integration into monitoring systems, standard infection control protocols for reusable medical equipment should be followed, including cleaning and disinfection as recommended by the manufacturer.
What regulatory pathway does this device follow?
The Picosat II SP02 Pulse Oximetry Module and M3001A Multi-Measurement Server holds FDA 510(k) clearance under the product code DQA, classified for cardiovascular applications. The clearance was granted through a special review process by the FDA’s Cardiovascular Advisory Committee, indicating a thorough evaluation of its substantial equivalence to a predicate device.
Can this device be used with other monitoring platforms?
Yes, the Picosat II SP02 module is designed as a modular component, meaning it is intended for integration into existing patient monitoring platforms that support its functionality. The M3001A Multi-Measurement Server serves as the central unit to process and aggregate data from connected modules, ensuring compatibility with systems that accommodate its specifications. Always verify compatibility with your specific monitoring platform before integration.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Picosat Ii Sp02 Pulse Oximetry Module and M3001a Multi-measurement ..., PDF FE.B 132004f o3 7 - Food and Drug Administration, Picosat Ii Sp02 Pulse Oximetry Module and M3001a Multi-measurement ..., PICOSAT II SPO2 PULSE OXIMETRY MODULE (K030973) — FDA 510(k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K033715 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems, Inc.
Sources (1)
- FDA 510(k) K033715 24 fields · synced Oct 1, 2026