The following data is part of a premarket notification filed by Snap Laboratories, L.l.c. with the FDA for Snap Model 6.
Device ID | K002095 |
510k Number | K002095 |
Device Name: | SNAP MODEL 6 |
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 | 2000-07-11 |
Decision Date | 2001-03-02 |