PRESTON LOWER LIMB CPM UNIT— 510(k) K852065

Name: FDA 510(k) clearance K852065
Creator: U.S. Food and Drug Administration
Published: 1985-07-19

Substantially Equivalent

Therapeutic Equipment Corp.

FDA 510(k) clearance K852065 for PRESTON LOWER LIMB CPM UNIT, Substantially Equivalent on 1985-07-19. Applicant: Therapeutic Equipment Corp.. Device class: 1.

Clearance details

Applicant: Therapeutic Equipment Corp.
Product code: Code BXB
Device class: Class 1
Regulation: 21 CFR 890.5380
Advisory panel: Physical Medicine
Date received: 1985-05-13
Decision date: 1985-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clifton, NJ, US

Download summary PDF View on FDA.gov ↗

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