HM-SPIRO

Spirometer, Diagnostic

HILL-MED, INC.

The following data is part of a premarket notification filed by Hill-med, Inc. with the FDA for Hm-spiro.

Pre-market Notification Details

Device IDK951718
510k NumberK951718
Device Name:HM-SPIRO
ClassificationSpirometer, Diagnostic
Applicant HILL-MED, INC. C/O REGULATORY/MARKET SERVICE P.O. BOX 2010 Palm Harbor,  FL  34682
ContactErnesto Ackerman
CorrespondentErnesto Ackerman
HILL-MED, INC. C/O REGULATORY/MARKET SERVICE P.O. BOX 2010 Palm Harbor,  FL  34682
Product CodeBZG  
CFR Regulation Number868.1840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-13
Decision Date1995-12-20

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