SUTTER CPM 5000

Exerciser, Finger, Powered

SUTTER BIOMEDICAL, INC.

The following data is part of a premarket notification filed by Sutter Biomedical, Inc. with the FDA for Sutter Cpm 5000.

Pre-market Notification Details

Device IDK830974
510k NumberK830974
Device Name:SUTTER CPM 5000
ClassificationExerciser, Finger, Powered
Applicant SUTTER BIOMEDICAL, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJFA  
CFR Regulation Number890.5410 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-03-28
Decision Date1983-04-12

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