SuperNO2VA Et Device
FDA 510(k) K173147 · Revolutionary Medical Devices, Inc.
510(k) numberK173147
Submission
- Device name
- SuperNO2VA Et Device
- Applicant
- Revolutionary Medical Devices, Inc.
Tucson, AZ, US - Received
- September 29, 2017
- Decision date
- June 20, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1400
- Specialty
- Anesthesiology
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More from Southmedic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K163277 | SuperNO2VA DeviceBSJ · Traditional | 10/13/2017SE |
Questions and answers
When was SuperNO2VA Et Device cleared by the FDA?
SuperNO2VA Et Device (K173147) received a 510(k) decision of Substantially Equivalent on June 20, 2018, 264 days after the submission was received.
What is the product code of K173147?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.