The following data is part of a premarket notification filed by Catheter Research, Inc. with the FDA for Disposable Airway Connectors For Gas Sampling.
| Device ID | K951345 |
| 510k Number | K951345 |
| Device Name: | DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING |
| Classification | Connector, Airway (extension) |
| Applicant | CATHETER RESEARCH, INC. 6131 WEST 80TH ST. Indianapolis, IN 46278 |
| Contact | John A Steen |
| Correspondent | John A Steen CATHETER RESEARCH, INC. 6131 WEST 80TH ST. Indianapolis, IN 46278 |
| Product Code | BZA |
| CFR Regulation Number | 868.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-23 |
| Decision Date | 1995-04-14 |