The following data is part of a premarket notification filed by Snap Diagnostics, L.l.c. with the FDA for Snap Model 8 Snoring And Apnea Recording And Analysis System.
| Device ID | K110064 |
| 510k Number | K110064 |
| Device Name: | SNAP MODEL 8 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM |
| Classification | Ventilatory Effort Recorder |
| Applicant | SNAP DIAGNOSTICS, L.L.C. 5210 Capitol Dr Wheeling, IL 60090 |
| Contact | Gil Raviv |
| Correspondent | Gil Raviv SNAP DIAGNOSTICS, L.L.C. 5210 Capitol Dr Wheeling, IL 60090 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-10 |
| Decision Date | 2011-03-18 |
| Summary: | summary |