The following data is part of a premarket notification filed by Snap Laboratories, L.l.c. with the FDA for Digi-snap.
| Device ID | K984169 |
| 510k Number | K984169 |
| Device Name: | DIGI-SNAP |
| Classification | Ventilatory Effort Recorder |
| Applicant | SNAP LABORATORIES, L.L.C. 3633 WEST LAKE AVE., SUITE 406 Glenview, IL 60025 |
| Contact | Gil Raviv |
| Correspondent | Gil Raviv SNAP LABORATORIES, L.L.C. 3633 WEST LAKE AVE., SUITE 406 Glenview, IL 60025 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-20 |
| Decision Date | 1999-05-26 |
| Summary: | summary |