The following data is part of a premarket notification filed by Biochem International, Inc. with the FDA for Biochem 8090 Capnograph.
| Device ID | K871133 |
| 510k Number | K871133 |
| Device Name: | BIOCHEM 8090 CAPNOGRAPH |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | BIOCHEM INTERNATIONAL, INC. W238 N1650 ROCKWOOD DR. Waukesha, WI 53186 |
| Contact | Keith R Harper |
| Correspondent | Keith R Harper BIOCHEM INTERNATIONAL, INC. W238 N1650 ROCKWOOD DR. Waukesha, WI 53186 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-20 |
| Decision Date | 1987-04-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30610586038192 | K871133 | 000 |