GOULD MODEL IM3000-IM3100 BATTERY POWER

Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

GOULD, INC.

The following data is part of a premarket notification filed by Gould, Inc. with the FDA for Gould Model Im3000-im3100 Battery Power.

Pre-market Notification Details

Device IDK830885
510k NumberK830885
Device Name:GOULD MODEL IM3000-IM3100 BATTERY POWER
ClassificationMonitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Applicant GOULD, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDRT  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-03-21
Decision Date1983-06-22

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