Somnotouch Resp
FDA 510(k) K140861 · Somnomedics GmbH
510(k) numberK140861
Submission
- Device name
- Somnotouch Resp
- Applicant
- Somnomedics GmbH
Randersacker, DE - Received
- April 3, 2014
- Decision date
- January 30, 2015
- 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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| K252628 | CassieMNR · Traditional | Wesper, Inc. | 04/27/2026SE |
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| K250882 | Sansa HsatMNR · Traditional | Huxley Medical | 10/29/2025SE |
| K250460 | WatchPAT400 (WP400)MNR · Traditional | Itamar Medical , Ltd. | 09/05/2025SE |
| K252383 | Somfit DMNR · Special | Compumedics Limited | 08/28/2025SE |
| K243220 | Onera STS 2 (ONERA STS 2)MNR · Traditional | Onera B.V. | 07/03/2025SE |
| K242224 | Happy Health Home Sleep TestMNR · Traditional | Happy Health, Inc. | 06/18/2025SE |
More from Happy Health, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K240700 | HomeSleepTest (HST, HST REM+)OLV · Traditional | 12/08/2024SE |
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| K212325 | EEG-acpGYB · Traditional | 06/15/2022SE |
| K201054 | SOMNOscreen plusOLV · Traditional | 08/12/2020SE |
| K081485 | SomnowatchMNR · Traditional | 09/18/2008SE |
| K071556 | Somnoscreen EEG10-20MNR · Special | 07/18/2007SE |
| K060708 | SomnoscreenMNR · Traditional | 01/24/2007SE |
Questions and answers
When was Somnotouch Resp cleared by the FDA?
Somnotouch Resp (K140861) received a 510(k) decision of Substantially Equivalent on January 30, 2015, 302 days after the submission was received.
What is the product code of K140861?
The FDA product code is MNR – Ventilatory Effort Recorder, a Class II (moderate risk) device regulated under 21 CFR 868.2375.