PEDIA-TEMP(TM) LIQUID-CIRCULATING HYPO-HYPERTHERM.— 510(k) K902268

Name: FDA 510(k) clearance K902268
Creator: U.S. Food and Drug Administration
Published: 1990-06-21

Substantially Equivalent

Seabrook Medical Systems, Inc.

FDA 510(k) clearance K902268 for PEDIA-TEMP(TM) LIQUID-CIRCULATING HYPO-HYPERTHERM., Substantially Equivalent on 1990-06-21. 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: 1990-05-21
Decision date: 1990-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

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