The following data is part of a premarket notification filed by Kirk Specialty Systems with the FDA for Capno-flo Regulator, Capno-flo.
Device ID | K952512 |
510k Number | K952512 |
Device Name: | CAPNO-FLO REGULATOR, CAPNO-FLO |
Classification | Ventilator, Emergency, Manual (resuscitator) |
Applicant | KIRK SPECIALTY SYSTEMS 1625 CRESCENT CIR., STE. 225 Carrollton, TX 75006 |
Contact | Dale Bickley |
Correspondent | Dale Bickley KIRK SPECIALTY SYSTEMS 1625 CRESCENT CIR., STE. 225 Carrollton, TX 75006 |
Product Code | BTM |
CFR Regulation Number | 868.5915 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-30 |
Decision Date | 1995-08-28 |