The following data is part of a premarket notification filed by Techtrade Llc with the FDA for Techno-scope Visual Stethoscope.
Device ID | K050097 |
510k Number | K050097 |
Device Name: | TECHNO-SCOPE VISUAL STETHOSCOPE |
Classification | Stethoscope, Electronic |
Applicant | TECHTRADE LLC 11900 GAINSBOROUGH ROAD P.O.BOX 2005 Potomac, MD 20854 -3305 |
Contact | Arthur M Horowitz |
Correspondent | Arthur M Horowitz TECHTRADE LLC 11900 GAINSBOROUGH ROAD P.O.BOX 2005 Potomac, MD 20854 -3305 |
Product Code | DQD |
CFR Regulation Number | 870.1875 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-01-14 |
Decision Date | 2005-09-30 |
Summary: | summary |