SomnaPatch
FDA 510(k) K183625 · Respironics, Inc.
510(k) numberK183625
Submission
- Device name
- SomnaPatch
- Applicant
- Respironics, Inc.
Murrysville, PA, US - Received
- December 26, 2018
- Decision date
- October 18, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MNR – Ventilatory Effort Recorder
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2375
- Specialty
- Anesthesiology
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Questions and answers
When was SomnaPatch cleared by the FDA?
SomnaPatch (K183625) received a 510(k) decision of Substantially Equivalent on October 18, 2019, 296 days after the submission was received.
What is the product code of K183625?
The FDA product code is MNR – Ventilatory Effort Recorder, a Class II (moderate risk) device regulated under 21 CFR 868.2375.