The following data is part of a premarket notification filed by Biochem International, Inc. with the FDA for Biochem 6100 Non-invasive Monitor.
| Device ID | K903222 |
| 510k Number | K903222 |
| Device Name: | BIOCHEM 6100 NON-INVASIVE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| 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 | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-23 |
| Decision Date | 1990-09-04 |