The following data is part of a premarket notification filed by Catheter Research, Inc. with the FDA for Disposable Gas Sampling Lines.
| Device ID | K946044 |
| 510k Number | K946044 |
| Device Name: | DISPOSABLE GAS SAMPLING LINES |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| 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 | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-12 |
| Decision Date | 1994-12-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50749756138388 | K946044 | 000 |
| 10080196983650 | K946044 | 000 |
| 10080196983667 | K946044 | 000 |
| 10080196983674 | K946044 | 000 |
| 10080196983698 | K946044 | 000 |
| 10080196983711 | K946044 | 000 |
| 10080196983803 | K946044 | 000 |
| 10080196984084 | K946044 | 000 |
| 10884389129180 | K946044 | 000 |
| 10080196146376 | K946044 | 000 |
| 10884389129166 | K946044 | 000 |
| 10884389129173 | K946044 | 000 |
| 10884389766453 | K946044 | 000 |