SPIROCAL

Calibrator, Pressure, Gas

EQUILIBRATED BIO SYSTEMS, INC.

The following data is part of a premarket notification filed by Equilibrated Bio Systems, Inc. with the FDA for Spirocal.

Pre-market Notification Details

Device IDK791294
510k NumberK791294
Device Name:SPIROCAL
ClassificationCalibrator, Pressure, Gas
Applicant EQUILIBRATED BIO SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeBXX  
CFR Regulation Number868.2620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-07-10
Decision Date1979-08-16

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.