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 |