The following data is part of a premarket notification filed by Health Technology Laboratories, Inc. with the FDA for Electrocardiograph, At-300 3 Channel.
Device ID | K790233 |
510k Number | K790233 |
Device Name: | ELECTROCARDIOGRAPH, AT-300 3 CHANNEL |
Classification | Electrocardiograph |
Applicant | HEALTH TECHNOLOGY LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DPS |
CFR Regulation Number | 870.2340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-02-02 |
Decision Date | 1979-02-08 |