COOL-AID— 510(k) K931203

Substantially Equivalent

Seabrook Medical Systems, Inc.

FDA 510(k) clearance K931203 for COOL-AID, Substantially Equivalent on 1994-02-22. Applicant: Seabrook Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Seabrook Medical Systems, Inc.
Product code: Code ILO
Device class: Class 2
Regulation: 21 CFR 890.5720
Advisory panel: Physical Medicine
Date received: 1993-03-09
Decision date: 1994-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, 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.