The following data is part of a premarket notification filed by Biotechnology, Inc. with the FDA for Biocheck Pec-108 Program-pulse Monitor.
| Device ID | K831752 |
| 510k Number | K831752 |
| Device Name: | BIOCHECK PEC-108 PROGRAM-PULSE MONITOR |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | BIOTECHNOLOGY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-01 |
| Decision Date | 1983-09-29 |