MONITOR HS8

Monitor, Breathing Frequency

SCIENTIFIC & GENERAL PTY. LTD.

The following data is part of a premarket notification filed by Scientific & General Pty. Ltd. with the FDA for Monitor Hs8.

Pre-market Notification Details

Device IDK782044
510k NumberK782044
Device Name:MONITOR HS8
ClassificationMonitor, Breathing Frequency
Applicant SCIENTIFIC & GENERAL PTY. LTD. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeBZQ  
CFR Regulation Number868.2375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-12-08
Decision Date1979-01-10

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