ELECTRO-PLETHYSMOGRAPH

Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

BIOTECX LABORATORIES, INC.

The following data is part of a premarket notification filed by Biotecx Laboratories, Inc. with the FDA for Electro-plethysmograph.

Pre-market Notification Details

Device IDK780761
510k NumberK780761
Device Name:ELECTRO-PLETHYSMOGRAPH
ClassificationPlethysmograph, Photoelectric, Pneumatic Or Hydraulic
Applicant BIOTECX LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJOM  
CFR Regulation Number870.2780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-05-09
Decision Date1978-06-30

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