Quality Life Technologies Compressor Nebulizer

by Quality Life Technologies., Co, Ltd 510(k)

Active United States

510(k) K112824

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK112824	Date21 Jun 2012Cleared	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Withdrawn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: K112824
FDA Product Code: CAF
FDA applicant: Quality Life Technologies Co;Ltd

Device Class: Class II
Regulation: 21 CFR Part 868.5630
Advisory Committee: Anesthesiology
FDA Decision: SESE Substantially Equivalent

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