The following data is part of a premarket notification filed by Somnomedics Gmbh with the FDA for Somnotouch Resp.
| Device ID | K140861 |
| 510k Number | K140861 |
| Device Name: | SOMNOTOUCH RESP |
| Classification | Ventilatory Effort Recorder |
| Applicant | SOMNOMEDICS GMBH AM SONNENSTUHL 63 Randersacker, DE D-97236 |
| Contact | Matthias Broenner |
| Correspondent | Matthias Broenner SOMNOMEDICS GMBH AM SONNENSTUHL 63 Randersacker, DE D-97236 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-03 |
| Decision Date | 2015-01-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250413410538 | K140861 | 000 |
| 04250413404162 | K140861 | 000 |
| 04250413404155 | K140861 | 000 |
| 04250413404094 | K140861 | 000 |
| 04250413404674 | K140861 | 000 |
| 04250413404124 | K140861 | 000 |
| 04250413404056 | K140861 | 000 |
| 04250413404049 | K140861 | 000 |
| 04250413402595 | K140861 | 000 |
| 04250413410859 | K140861 | 000 |
| 04250413410842 | K140861 | 000 |
| 04250413404179 | K140861 | 000 |
| 04250413404186 | K140861 | 000 |
| 04250413404193 | K140861 | 000 |
| 04250413404643 | K140861 | 000 |
| 04250413404612 | K140861 | 000 |
| 04250413404513 | K140861 | 000 |
| 04250413404469 | K140861 | 000 |
| 04250413404391 | K140861 | 000 |
| 04250413404339 | K140861 | 000 |
| 04250413404322 | K140861 | 000 |
| 04250413404223 | K140861 | 000 |
| 04250413404216 | K140861 | 000 |
| 04250413404209 | K140861 | 000 |
| 04250413410835 | K140861 | 000 |