Novaerus NV1050
FDA 510(k) K200321 · Novaerus Us, Inc.
510(k) numberK200321
Submission
- Device name
- Novaerus NV1050
- Applicant
- Novaerus Us, Inc.
Stamford, CT, US - Received
- February 10, 2020
- Decision date
- December 28, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRF – Cleaner, Air, Medical Recirculating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5045
- Specialty
- General Hospital
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| K220298 | CerroZone MobileFRF · Traditional | Cerrozone | 07/01/2022SE |
| K130702 | Airsonett AIR-4FRF · Traditional | Airsonett AB | 07/23/2013SE |
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Questions and answers
When was Novaerus NV1050 cleared by the FDA?
Novaerus NV1050 (K200321) received a 510(k) decision of Substantially Equivalent on December 28, 2020, 322 days after the submission was received.
What is the product code of K200321?
The FDA product code is FRF – Cleaner, Air, Medical Recirculating, a Class II (moderate risk) device regulated under 21 CFR 880.5045.