Medinet Incentive Spirometers - Respiprogram

by Medinet SRL 510(k)

Active United States

510(k) K160837

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK160837	Date23 Feb 2017Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k)

510(k) Number: K160837
FDA Product Code: BWF

Device Class: Class II
Regulation: 21 CFR Part 868.5690
Advisory Committee: Anesthesiology
FDA Decision: SESE Substantially Equivalent

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