The following data is part of a premarket notification filed by Biochem International, Inc. with the FDA for Biochem 9100 Multigas Monitor.
| Device ID | K901861 |
| 510k Number | K901861 |
| Device Name: | BIOCHEM 9100 MULTIGAS MONITOR |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | BIOCHEM INTERNATIONAL, INC. W238 N1650 ROCKWOOD DR. Waukesha, WI 53186 |
| Contact | David A Uhen |
| Correspondent | David A Uhen 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 | 1990-04-25 |
| Decision Date | 1990-07-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15019517042535 | K901861 | 000 |
| 15019517042528 | K901861 | 000 |