MODEL# 7500 SURVEYOR

Ventilatory Effort Recorder

DEVILBISS HEALTH CARE, INC.

The following data is part of a premarket notification filed by Devilbiss Health Care, Inc. with the FDA for Model# 7500 Surveyor.

Pre-market Notification Details

Device IDK944611
510k NumberK944611
Device Name:MODEL# 7500 SURVEYOR
ClassificationVentilatory Effort Recorder
Applicant DEVILBISS HEALTH CARE, INC. 1200 EAST MAIN ST. P.O.BOX 635 Somerset,  PA  15501 -0635
ContactMark D'angelo
CorrespondentMark D'angelo
DEVILBISS HEALTH CARE, INC. 1200 EAST MAIN ST. P.O.BOX 635 Somerset,  PA  15501 -0635
Product CodeMNR  
CFR Regulation Number868.2375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-09-19
Decision Date1995-04-21

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