The following data is part of a premarket notification filed by Southmedic, Inc. with the FDA for Oxyarm Co2.
| Device ID | K014211 |
| 510k Number | K014211 |
| Device Name: | OXYARM CO2 |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | SOUTHMEDIC, INC. 6329 W. WATERVIEW CT. Mccordsville, IN 46051 -9501 |
| Contact | Paul E Dryden |
| Correspondent | Paul E Dryden SOUTHMEDIC, INC. 6329 W. WATERVIEW CT. Mccordsville, IN 46051 -9501 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-21 |
| Decision Date | 2002-06-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00620974003199 | K014211 | 000 |
| 00620974003144 | K014211 | 000 |
| 00620974003113 | K014211 | 000 |