AIRPERFECT 1000 (SINGLE-USER SYSTEM), AIRPERFECT 2000 (MULTI-USER SYSTEM)— 510(k) K951684

Name: FDA 510(k) clearance K951684
Creator: U.S. Food and Drug Administration
Published: 1995-10-06

Substantially Equivalent

Digital Air Corp.

FDA 510(k) clearance K951684 for AIRPERFECT 1000 (SINGLE-USER SYSTEM), AIRPERFECT 2000 (MULTI-USER SYSTEM), Substantially Equivalent on 1995-10-06. Applicant: Digital Air Corp.. Device class: 2.

Clearance details

Applicant: Digital Air Corp.
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 1995-04-11
Decision date: 1995-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

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