The following data is part of a premarket notification filed by Hd Medical, Inc. with the FDA for Hd Steth.
Device ID | K201299 |
510k Number | K201299 |
Device Name: | HD Steth |
Classification | Stethoscope, Electronic |
Applicant | HD Medical, Inc. 3561 Homestead Road #146 Santa Clara, CA 95051 |
Contact | Stephanie Anderson |
Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
Product Code | DQD |
CFR Regulation Number | 870.1875 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2020-05-15 |
Decision Date | 2020-07-10 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HD STETH 87040716 not registered Dead/Abandoned |
HD Medical, Inc. 2016-05-17 |