GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM

Dynamometer, Ac-powered

GREENLEAF MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Greenleaf Medical Systems, Inc. with the FDA for Greenleaf Eval System/ Greenleaf Solosystem.

Pre-market Notification Details

Device IDK935757
510k NumberK935757
Device Name:GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM
ClassificationDynamometer, Ac-powered
Applicant GREENLEAF MEDICAL SYSTEMS, INC. 2248 PARK BLVD. Palo Alto,  CA  94306
ContactGlenn R Edwards
CorrespondentGlenn R Edwards
GREENLEAF MEDICAL SYSTEMS, INC. 2248 PARK BLVD. Palo Alto,  CA  94306
Product CodeLBB  
CFR Regulation Number888.1240 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-11-26
Decision Date1994-04-15

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