The following data is part of a premarket notification filed by Westmed, Inc. with the FDA for Pedi Co2 Easy.
| Device ID | K072220 |
| 510k Number | K072220 |
| Device Name: | PEDI CO2 EASY |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | Westmed, Inc. 5580 S. NOGALES HIGHWAY Tucson, AZ 85706 |
| Contact | Dale Bickley |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-08-10 |
| Decision Date | 2007-08-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00709078621352 | K072220 | 000 |
| 20709078621349 | K072220 | 000 |
| 20888277660189 | K072220 | 000 |