INFRASONDE AUTO/INFLATOR ELEC. VIBRATOR

System, Phonocatheter, Intracavitary

SPHYGMETRICS, INC.

The following data is part of a premarket notification filed by Sphygmetrics, Inc. with the FDA for Infrasonde Auto/inflator Elec. Vibrator.

Pre-market Notification Details

Device IDK800179
510k NumberK800179
Device Name:INFRASONDE AUTO/INFLATOR ELEC. VIBRATOR
ClassificationSystem, Phonocatheter, Intracavitary
Applicant SPHYGMETRICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDXW  
CFR Regulation Number870.1270 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-01-29
Decision Date1980-02-11

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