The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Carbon Dioxide (c02).
| Device ID | K942735 |
| 510k Number | K942735 |
| Device Name: | CARBON DIOXIDE (C02) |
| Classification | Enzymatic, Carbon-dioxide |
| Applicant | TECO DIAGNOSTICS 911 VIA RODEO Placentia, CA 92670 |
| Contact | K.c. Chen |
| Correspondent | K.c. Chen TECO DIAGNOSTICS 911 VIA RODEO Placentia, CA 92670 |
| Product Code | KHS |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-10 |
| Decision Date | 1995-03-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10673486001624 | K942735 | 000 |