REM-AIR— 510(k) K924686

Substantially Equivalent

Mellenair Ent., Inc.

FDA 510(k) clearance K924686 for REM-AIR, Substantially Equivalent on 1993-02-12. Applicant: Mellenair Ent., Inc.. Device class: 2.

Clearance details

Applicant: Mellenair Ent., Inc.
Product code: Code INX
Device class: Class 2
Regulation: 21 CFR 890.5160
Advisory panel: Physical Medicine
Date received: 1992-09-16
Decision date: 1993-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Long Beach, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.