The following data is part of a premarket notification filed by Kirk Specialty Systems with the FDA for Capno-flo(tm) Regulator.
| Device ID | K945822 |
| 510k Number | K945822 |
| Device Name: | CAPNO-FLO(TM) REGULATOR |
| Classification | Valve, Non-rebreathing |
| Applicant | KIRK SPECIALTY SYSTEMS 1624 CEWSCENT CIRCLE SUITE 225 Carrollton, TX 75006 |
| Contact | Dale Bickley |
| Correspondent | Dale Bickley KIRK SPECIALTY SYSTEMS 1624 CEWSCENT CIRCLE SUITE 225 Carrollton, TX 75006 |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-29 |
| Decision Date | 1995-02-24 |