The following data is part of a premarket notification filed by Britt Corp., Inc. with the FDA for Fitness Logger.
Device ID | K840020 |
510k Number | K840020 |
Device Name: | FITNESS LOGGER |
Classification | Electrocardiograph |
Applicant | BRITT CORP., INC. Chanhassen , MN 55317 - |
Contact | Axel M Fritz |
Correspondent | Axel M Fritz BRITT CORP., INC. Chanhassen , MN 55317 - |
Product Code | DPS |
CFR Regulation Number | 870.2340 [🔎] |
Decision | Se - Postmarket Surveillance Required (SESP) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-01-05 |
Decision Date | 1984-10-26 |