Adscope® 658BD

by American Diagnostic Corporation

Adscope® 658BD is a Class II device made by American Diagnostic Corporation, cleared under FDA 510(k) K162589 on 10 Mar 2017 and listed in FDA GUDID since 31 Mar 2017 (UDI-DI 00634782083298), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00634782083298 UDI-DI	Date31 Mar 2017Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK162589	Date10 Mar 2017Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00634782083298
FDA 510(k) database 510(k) number K162589

Across registries

2 registries list this device

FDA 510(k) K162589 decided 10 Mar 2017 Active
FDA GUDID UDI-DI 00634782083298 listed 31 Mar 2017 Listed

Timeline

2 dated events

10 Mar 2017 Cleared FDA 510(k) K162589
31 Mar 2017 Listed FDA GUDID 00634782083298

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Adscope®
Generic name: Electronic acoustic stethoscope
Model / Ref / Catalog: 658BD

Primary DI / UDI-DI: 00634782083298
510(k) Number: K162589
FDA product code: DQD
GMDN term: Electronic acoustic stethoscope

Device class: Class II
Regulation number: 870.1875
GUDID distribution status: In Commercial Distribution

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Properties

Over-the-counter
Lot / batch number

Other properties (13, all answered No)