Somnoscreen EEG10-20
FDA 510(k) K071556 · Somnomedics GmbH
510(k) numberK071556
Submission
- Device name
- Somnoscreen EEG10-20
- Applicant
- Somnomedics GmbH
Washington, DC, US - Received
- June 7, 2007
- Decision date
- July 18, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K201054 | SOMNOscreen plusOLV · Traditional | 08/12/2020SE |
| K140861 | Somnotouch RespMNR · Traditional | 01/30/2015SE |
| K081485 | SomnowatchMNR · Traditional | 09/18/2008SE |
| K060708 | SomnoscreenMNR · Traditional | 01/24/2007SE |
Questions and answers
When was Somnoscreen EEG10-20 cleared by the FDA?
Somnoscreen EEG10-20 (K071556) received a 510(k) decision of Substantially Equivalent on July 18, 2007, 41 days after the submission was received.
What is the product code of K071556?
The FDA product code is MNR – Ventilatory Effort Recorder, a Class II (moderate risk) device regulated under 21 CFR 868.2375.