Life Sound Sensor

by Flowscan, Inc. 510(k)

Active United States

510(k) K952651

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK952651	Date19 Sep 1995Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K952651
FDA Product Code: DQC

Device Class: Class I
Regulation: 21 CFR Part 870.2390
Advisory Committee: Cardiovascular
FDA Decision: SESE Substantially Equivalent

Other devices from Flowscan, Inc.

Life Sound Sensor Amplifier-Lisa

Class II