Identifiers
- 510(k) Number
- K092217 FDA 510(k)
- FDA Product Code
- BZK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.1850 FDA 510(k)
- Regulation Number
- 868.1850 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Mercury Vco2 is a spirometer, monitoring device with or without alarm. It is designed to measure and monitor respiratory parameters as part of clinical anesthesia applications.
This device is regulated under FDA 510(k) clearance number K092217. It is classified as a class 2 medical device under regulation number 868.1850.
Frequently asked questions
What is the primary clinical use of the Mercury VCO2?
The Mercury VCO2 is a spirometer and monitoring device specifically designed to measure and monitor respiratory parameters during clinical anesthesia applications.
Is the Mercury VCO2 a regulated medical device?
Yes, the Mercury VCO2 is a class 2 medical device regulated under FDA 510(k) clearance number K092217, which indicates it has been found substantially equivalent to legally marketed predicate devices.
Under which medical specialty is this device categorized?
The Mercury VCO2 is categorized under the anesthesiology medical specialty, as it is intended for use in clinical anesthesia settings to monitor patient respiratory data.
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: MERCURY VCO2 510 (k) K092217 - FDA.report, MERCURY VCO2 MODULE WITH CAPNOSTAT 5 - fda.report, About Respironics Novametrix | 40 Years of Capnography Innovation, Respironics Novametrix Capnography Solutions | OEM CO₂ Monitoring
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K092217 | Class II | Active |
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Manufacturer
- Manufacturer
- Respironics Novametrix, LLC
- FDA Applicant
- Respironics Novametrix, Inc.
Sources (1)
- FDA 510(k) K092217 24 fields · synced Sep 25, 2026