The following data is part of a premarket notification filed by Hudson Respiratory Care, Inc. with the FDA for Dual Lumen Oxygen Delivery Gas Sampling Cannula.
| Device ID | K961150 |
| 510k Number | K961150 |
| Device Name: | DUAL LUMEN OXYGEN DELIVERY GAS SAMPLING CANNULA |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | HUDSON RESPIRATORY CARE, INC. 27711 DIAZ RD. Temecula, CA 92390 -0740 |
| Contact | Arden Morley |
| Correspondent | Arden Morley HUDSON RESPIRATORY CARE, INC. 27711 DIAZ RD. Temecula, CA 92390 -0740 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-22 |
| Decision Date | 1996-09-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14026704580320 | K961150 | 000 |
| 24026704580341 | K961150 | 000 |
| 24026704580334 | K961150 | 000 |
| 24026704580327 | K961150 | 000 |
| 34026704744498 | K961150 | 000 |
| 34026704744481 | K961150 | 000 |
| 34026704744474 | K961150 | 000 |
| 34026704744467 | K961150 | 000 |
| 34026704744450 | K961150 | 000 |
| 24026704717853 | K961150 | 000 |
| 24026704717860 | K961150 | 000 |
| 24026704717877 | K961150 | 000 |
| 14026704610393 | K961150 | 000 |
| 24026704610383 | K961150 | 000 |
| 24026704672725 | K961150 | 000 |
| 24026704672718 | K961150 | 000 |
| 24026704672701 | K961150 | 000 |
| 24026704658194 | K961150 | 000 |
| 24026704658187 | K961150 | 000 |
| 24026704657012 | K961150 | 000 |
| 34026704744443 | K961150 | 000 |