RESPIRATORY FLOW MODULE

Pneumotachometer

THORATEC LABORATORIES CORP.

The following data is part of a premarket notification filed by Thoratec Laboratories Corp. with the FDA for Respiratory Flow Module.

Pre-market Notification Details

Device IDK833265
510k NumberK833265
Device Name:RESPIRATORY FLOW MODULE
ClassificationPneumotachometer
Applicant THORATEC LABORATORIES CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJAX  
CFR Regulation Number868.2550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-09-21
Decision Date1983-11-28

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