The following data is part of a premarket notification filed by Imediplus Inc. with the FDA for Electronic Stethoscope Ds3011a.
Device ID | K173663 |
510k Number | K173663 |
Device Name: | Electronic Stethoscope DS3011A |
Classification | Stethoscope, Electronic |
Applicant | IMEDIPLUS INC. 2F, 12, Shengyi Rd.Sec.2 Chupei City, TW 30261 |
Contact | Shirley Lai |
Correspondent | Shirley Lai IMEDIPLUS INC. 2F, 12, Shengyi Rd.Sec.2 Chupei City, TW 30261 |
Product Code | DQD |
CFR Regulation Number | 870.1875 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-11-29 |
Decision Date | 2018-08-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04719874400040 | K173663 | 000 |