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510(k) K200567

ASI Plethysmogrpah Analyzer by Arterial Stiffness, Inc. — Product Code JOM

K200567 is an FDA 510(k) premarket notification submitted by Arterial Stiffness, Inc. for the device "ASI Plethysmogrpah Analyzer". The FDA issued a decision of Substantially Equivalent on February 26, 2021. The device falls under product code JOM (Plethysmograph, Photoelectric, Pneumatic Or Hydraulic), a Class II device regulated under 21 CFR 870.2780.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2021
Date Received
March 4, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Device Class
Class II
Regulation Number
870.2780
Review Panel
CV
Submission Type

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FDA data resources