The following data is part of a premarket notification filed by Gv Concepts with the FDA for Doctorgram Stethoscope Des-i.
Device ID | K210736 |
510k Number | K210736 |
Device Name: | Doctorgram Stethoscope DES-I |
Classification | Stethoscope, Electronic |
Applicant | GV Concepts 3240 S White Rd #286 San Jose, CA 95148 |
Contact | Ching-kay Chow |
Correspondent | Faye Liu GV Concepts 3034 Bradshaw Dr San Jose, CA 95148 |
Product Code | DQD |
CFR Regulation Number | 870.1875 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-03-11 |
Decision Date | 2021-07-27 |