The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Telemetry System, Biotel 300.
| Device ID | K781836 |
| 510k Number | K781836 |
| Device Name: | TELEMETRY SYSTEM, BIOTEL 300 |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | SPACELABS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-10-30 |
| Decision Date | 1978-12-04 |