CARDIAC COOLING JACKET— 510(k) K851077

Substantially Equivalent

Pat O. Daily

FDA 510(k) clearance K851077 for CARDIAC COOLING JACKET, Substantially Equivalent on 1985-07-11. Applicant: Pat O. Daily. Device class: 1.

Clearance details

Applicant: Pat O. Daily
Product code: Code KRI
Device class: Class 1
Regulation: 21 CFR 870.4200
Advisory panel: Cardiovascular
Date received: 1985-03-18
Decision date: 1985-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, 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.