PNEUPAC VR1 AIR MIX

Ventilator, Emergency, Powered (resuscitator)

SMITHS MEDICAL INTERNATIONAL, LTD.

The following data is part of a premarket notification filed by Smiths Medical International, Ltd. with the FDA for Pneupac Vr1 Air Mix.

Pre-market Notification Details

Device IDK071527
510k NumberK071527
Device Name:PNEUPAC VR1 AIR MIX
ClassificationVentilator, Emergency, Powered (resuscitator)
Applicant SMITHS MEDICAL INTERNATIONAL, LTD. N7 W22025 JOHNSON DRIVE Waukesha,  WI  53186
ContactDonald Alexander
CorrespondentDonald Alexander
SMITHS MEDICAL INTERNATIONAL, LTD. N7 W22025 JOHNSON DRIVE Waukesha,  WI  53186
Product CodeBTL  
CFR Regulation Number868.5925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-06-04
Decision Date2007-10-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
35019315074862 K071527 000

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