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 |