Oscillomate NIBP / SP02 EMS Monitor
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K980879 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 Oscillomate NIBP / Sp02 EMS Monitor is a portable, battery-powered patient monitor that non-invasively measures blood pressure via oscillometric technique and oxygen saturation (SpO2) and pulse rate via pulse oximetry. It is designed for use by healthcare professionals in emergency medical services (EMS) environments for adult and pediatric patients.
The device provides spot-check monitoring with readings that can be taken manually or at intervals of 1-60 minutes. It is supplied as a portable unit and is operated by healthcare professionals. The device has received FDA 510(k) clearance with K number K980879 and is classified under product code DQA.
Frequently asked questions
What is the Oscillomate NIBP / Sp02 EMS Monitor used for?
The Oscillomate NIBP / Sp02 EMS Monitor is designed for healthcare professionals in emergency medical services to non-invasively measure blood pressure via oscillometric technique and oxygen saturation (SpO2) and pulse rate via pulse oximetry in both adult and pediatric patients.
How is the Oscillomate NIBP / Sp02 EMS Monitor supplied and operated?
The device is supplied as a portable unit that is operated by healthcare professionals. It provides spot-check monitoring with readings that can be taken manually or at intervals of 1-60 minutes, making it suitable for various emergency medical situations.
What is the regulatory status of the Oscillomate NIBP / Sp02 EMS Monitor?
The device has received FDA 510(k) clearance with K number K980879 and is classified under product code DQA. It was determined to be substantially equivalent through a traditional clearance process by the Cardiovascular advisory committee.
Is the Oscillomate NIBP / Sp02 EMS Monitor reusable or single-use?
The device is designed as a portable unit for repeated use by healthcare professionals in EMS environments. While specific details about reusability aren't provided in the device data, its design as a battery-powered monitor suggests it's intended for multiple patient encounters rather than single-use.
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: OSCILLOMATE NIBP / SP02 EMS MONITOR - Innolitics, fda.innolitics.com, PDF K980879 - Oscillomate Nibp / Sp02 Ems Monitor, OSCILLOMATE NIBP / SP02 EMS MONITOR 510(k) K980879 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K980879 | Class II | Active |
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Manufacturer
- Manufacturer
- Cas Medical Systems, Inc.
Sources (1)
- FDA 510(k) K980879 24 fields · synced Oct 6, 2026