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 |