SOLA, COUNTER-PULSATION, MODEL SECP-S— 510(k) K022078

Name: FDA 510(k) clearance K022078
Creator: U.S. Food and Drug Administration
Published: 2003-01-10

Substantially Equivalent

Sola Medical Devices, LLC

FDA 510(k) clearance K022078 for SOLA, COUNTER-PULSATION, MODEL SECP-S, Substantially Equivalent on 2003-01-10. Applicant: Sola Medical Devices, LLC. Device class: 2.

Clearance details

Applicant: Sola Medical Devices, LLC
Product code: Code DRN
Device class: Class 2
Regulation: 21 CFR 870.5225
Advisory panel: Cardiovascular
Date received: 2002-06-26
Decision date: 2003-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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