The following data is part of a premarket notification filed by Biochem International, Inc. with the FDA for Biochem 9100 Multigas Monitor Ibp Module.
| Device ID | K921388 |
| 510k Number | K921388 |
| Device Name: | BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE |
| Classification | Computer, Blood-pressure |
| Applicant | BIOCHEM INTERNATIONAL, INC. W238 N1650 ROCKWOOD DR. Waukesha, WI 53186 |
| Contact | David Uhen |
| Correspondent | David Uhen BIOCHEM INTERNATIONAL, INC. W238 N1650 ROCKWOOD DR. Waukesha, WI 53186 |
| Product Code | DSK |
| CFR Regulation Number | 870.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-23 |
| Decision Date | 1993-05-26 |