The following data is part of a premarket notification filed by Suzuken Co., Ltd. with the FDA for Electrocardiograph Interpreter.
Device ID | K822968 |
510k Number | K822968 |
Device Name: | ELECTROCARDIOGRAPH INTERPRETER |
Classification | Detector And Alarm, Arrhythmia |
Applicant | SUZUKEN CO., LTD. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DSI |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-10-07 |
Decision Date | 1982-12-15 |