AusculThing Acc
by Ausculthing OY Finland 510(k)
510(k) K230823
Product code DQD
Overview
The AusculThing Acc is an Electronic Stethoscope, classified as a class 2 device. It is substantially equivalent and has a regulation number of 870.1875.
The device is supplied by Ausculthing OY and has been authorized with an FDA 510K clearance. It is used in the Cardiovascular medical specialty and has a product code of DQD.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK230823 | Date12 Jul 2023 | StatusActive |
Coverage
- Active
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DQD
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1875
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K230823