A.S.A.P.— 510(k) K841318

Substantially Equivalent

Trimedyne, Inc.

FDA 510(k) clearance K841318 for A.S.A.P., Substantially Equivalent on 1984-07-18. Applicant: Trimedyne, Inc.. Device class: 2.

Clearance details

Applicant: Trimedyne, Inc.
Product code: Code LDR
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 1984-04-02
Decision date: 1984-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.