(DATAGLOVE) HAND IMPAIRMENT EVALUATION SYSTEM

Goniometer, 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 (dataglove) Hand Impairment Evaluation System.

Pre-market Notification Details

Device IDK884723
510k NumberK884723
Device Name:(DATAGLOVE) HAND IMPAIRMENT EVALUATION SYSTEM
ClassificationGoniometer, Ac-powered
Applicant GREENLEAF MEDICAL SYSTEMS, INC. 2248 PARK BLVD. Palo Alto,  CA  94306
ContactSeelig, Phd
CorrespondentSeelig, Phd
GREENLEAF MEDICAL SYSTEMS, INC. 2248 PARK BLVD. Palo Alto,  CA  94306
Product CodeKQX  
CFR Regulation Number888.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-11-10
Decision Date1989-02-08

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