VITALOGRAPH COMPACT

Spirometer, Diagnostic

VITALOGRAPH LTD.

The following data is part of a premarket notification filed by Vitalograph Ltd. with the FDA for Vitalograph Compact.

Pre-market Notification Details

Device IDK854526
510k NumberK854526
Device Name:VITALOGRAPH COMPACT
ClassificationSpirometer, Diagnostic
Applicant VITALOGRAPH LTD. 8347 QUIVIRA RD. Lenexa,  KS  66215
ContactLovina G Freeman
CorrespondentLovina G Freeman
VITALOGRAPH LTD. 8347 QUIVIRA RD. Lenexa,  KS  66215
Product CodeBZG  
CFR Regulation Number868.1840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-11-13
Decision Date1985-12-24

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05099169678019 K854526 000

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