The following data is part of a premarket notification filed by S.l.p Ltd. with the FDA for Sleepstrip Ii.
| Device ID | K112822 |
| 510k Number | K112822 |
| Device Name: | SLEEPSTRIP II |
| Classification | Ventilatory Effort Recorder |
| Applicant | S.L.P LTD. 62 ANILEVITZ STREET Tel-aviv, IL 67060 |
| Contact | Noam Hadas |
| Correspondent | Noam Hadas S.L.P LTD. 62 ANILEVITZ STREET Tel-aviv, IL 67060 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-28 |
| Decision Date | 2011-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857825005013 | K112822 | 000 |
| 07290013818171 | K112822 | 000 |