The following data is part of a premarket notification filed by Industrial & Biomedical Sensors Corp. with the FDA for Ct-1600 Digital Pulse Rate Monitor.
| Device ID | K802204 |
| 510k Number | K802204 |
| Device Name: | CT-1600 DIGITAL PULSE RATE MONITOR |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | INDUSTRIAL & BIOMEDICAL SENSORS CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-11 |
| Decision Date | 1980-10-03 |