The following data is part of a premarket notification filed by Influent Ltd. with the FDA for Sleepstrip Disposable Apnea Screener.
| Device ID | K002135 |
| 510k Number | K002135 |
| Device Name: | SLEEPSTRIP DISPOSABLE APNEA SCREENER |
| Classification | Ventilatory Effort Recorder |
| Applicant | INFLUENT LTD. 555 THIRTEENTH STREET, N.W. Washington, DC |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan INFLUENT LTD. 555 THIRTEENTH STREET, N.W. Washington, DC |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-14 |
| Decision Date | 2000-12-06 |