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510(k) K022078

SOLA, COUNTER-PULSATION, MODEL SECP-S by Sola Medical Devices, LLC — Product Code DRN

K022078 is an FDA 510(k) premarket notification submitted by Sola Medical Devices, LLC for the device "SOLA, COUNTER-PULSATION, MODEL SECP-S". The FDA issued a decision of Substantially Equivalent on January 10, 2003. The device falls under product code DRN (Device, Counter-Pulsating, External), a Class II device regulated under 21 CFR 870.5225.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2003
Date Received
June 26, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Counter-Pulsating, External
Device Class
Class II
Regulation Number
870.5225
Review Panel
CV
Submission Type

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FDA data resources