The following data is part of a premarket notification filed by Biotechnology, Inc. with the FDA for Coach Tm- The Aerobic Fitness Monitor.
| Device ID | K851335 |
| 510k Number | K851335 |
| Device Name: | COACH TM- THE AEROBIC FITNESS MONITOR |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | BIOTECHNOLOGY, INC. 6924 NW 46TH. ST. Miami, FL 33166 |
| Contact | Frank J Bianco |
| Correspondent | Frank J Bianco BIOTECHNOLOGY, INC. 6924 NW 46TH. ST. Miami, FL 33166 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-03 |
| Decision Date | 1985-07-24 |