The following data is part of a premarket notification filed by Westmed, Inc. with the FDA for Westmed Gas Sampling Cannula With O2 Delivery.
| Device ID | K162343 |
| 510k Number | K162343 |
| Device Name: | Westmed Gas Sampling Cannula With O2 Delivery |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | WESTMED, INC. 5580 S NOGALES HWY Tucson, AZ 85706 |
| Contact | Diana Upp |
| Correspondent | Paul Dryden WESTMED, INC. 5580 S NOGALES HWY Tucson, AZ 85706 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-22 |
| Decision Date | 2016-12-14 |
| Summary: | summary |