The following data is part of a premarket notification filed by Biochem International, Inc. with the FDA for 8100 Anesthetic Agent Monitor.
| Device ID | K932389 |
| 510k Number | K932389 |
| Device Name: | 8100 ANESTHETIC AGENT MONITOR |
| Classification | Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.) |
| Applicant | BIOCHEM INTERNATIONAL, INC. W238 N1650 ROCKWOOD DR. Waukesha, WI 53186 |
| Contact | Scott J Pease |
| Correspondent | Scott J Pease BIOCHEM INTERNATIONAL, INC. W238 N1650 ROCKWOOD DR. Waukesha, WI 53186 |
| Product Code | CBS |
| CFR Regulation Number | 868.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-17 |
| Decision Date | 1993-12-03 |