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510(k) K882547

VARITEST by Eureka AB — Product Code JOM

K882547 is an FDA 510(k) premarket notification submitted by Eureka AB for the device "VARITEST". The FDA issued a decision of Substantially Equivalent on November 3, 1988. 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
November 3, 1988
Date Received
June 21, 1988
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