HTP-1500 LOCALIZED HEAT THERAPY PUMP— 510(k) K970197

Name: FDA 510(k) clearance K970197
Creator: U.S. Food and Drug Administration
Published: 1997-09-10

Substantially Equivalent

Adroit Medical Systems, Inc.

FDA 510(k) clearance K970197 for HTP-1500 LOCALIZED HEAT THERAPY PUMP, Substantially Equivalent on 1997-09-10. Applicant: Adroit Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Adroit Medical Systems, Inc.
Product code: Code ILO
Device class: Class 2
Regulation: 21 CFR 890.5720
Advisory panel: Physical Medicine
Date received: 1997-01-21
Decision date: 1997-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Loudon, TN, US

Download summary PDF View on FDA.gov ↗

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