Horizon 2000 Pulse Oximetry and Module
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K882273 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 Horizon 2000 Pulse Oximetry and Module is an oximeter device classified under product code DQA and regulation 870.2700. It is designed for cardiovascular applications and was reviewed by the Anesthesiology advisory panel.
The device received FDA 510(k) clearance K882273 on August 25, 1988, as a substantially equivalent device. It is classified as a Class II medical device and was manufactured by Mennen Medical, Inc. in Clarence, NY.
Frequently asked questions
What is the Horizon 2000 Pulse Oximetry and Module used for?
The Horizon 2000 Pulse Oximetry and Module is designed for cardiovascular applications, as indicated by its classification under product code DQA and review by the Anesthesiology advisory panel, making it suitable for monitoring oxygen saturation in cardiovascular care settings.
How was the Horizon 2000 Pulse Oximetry and Module cleared for market?
The device received FDA 510(k) clearance K882273 on August 25, 1988, as a substantially equivalent device under the Traditional clearance pathway, based on its similarity to legally marketed predicate devices.
What regulatory classification does the Horizon 2000 Pulse Oximetry and Module have?
The Horizon 2000 Pulse Oximetry and Module is classified as a Class II medical device under FDA regulation 870.2700 and product code DQA, reflecting its moderate risk level and intended cardiovascular 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: HORIZON 2000 PULSE OXIMETRY AND MODULE - Innolitics, HORIZON 2000 PULSE OXIMETRY AND MODULE 510(k) K882273 - fda.report, Horizon 2000 Pulse Oximetry and Module - Beudamed, HORIZON 2000 PULSE OXIMETRY AND MODULE - Innolitics, Horizon 2000 Pulse Oximetry (Sao2) Monitor Capabil
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K882273 | Class II | Active |
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Manufacturer
- Manufacturer
- Mennen Medical, Inc.
Sources (1)
- FDA 510(k) K882273 24 fields · synced Oct 6, 2026