DISPOSABLE BACTERIOLOGICAL FILTER

Spirometer, Diagnostic

VITALOGRAPH, INC.

The following data is part of a premarket notification filed by Vitalograph, Inc. with the FDA for Disposable Bacteriological Filter.

Pre-market Notification Details

Device IDK942779
510k NumberK942779
Device Name:DISPOSABLE BACTERIOLOGICAL FILTER
ClassificationSpirometer, Diagnostic
Applicant VITALOGRAPH, INC. 8347 QUIVIRA RD. Lenexa,  KS  66215
ContactPhil Hemes
CorrespondentPhil Hemes
VITALOGRAPH, INC. 8347 QUIVIRA RD. Lenexa,  KS  66215
Product CodeBZG  
CFR Regulation Number868.1840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-06-13
Decision Date1994-07-13

NIH GUDID Devices

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