RUSCH MANUAL RESUSCITATOR BAG

Ventilator, Emergency, Manual (resuscitator)

RUSCH, INC.

The following data is part of a premarket notification filed by Rusch, Inc. with the FDA for Rusch Manual Resuscitator Bag.

Pre-market Notification Details

Device IDK993194
510k NumberK993194
Device Name:RUSCH MANUAL RESUSCITATOR BAG
ClassificationVentilator, Emergency, Manual (resuscitator)
Applicant RUSCH, INC. 2450 MEADOWBROOK PKWY. Duluth,  GA  30096
ContactRonald Young
CorrespondentRonald Young
RUSCH, INC. 2450 MEADOWBROOK PKWY. Duluth,  GA  30096
Product CodeBTM  
CFR Regulation Number868.5915 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-09-23
Decision Date2000-03-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00627843557579 K993194 000
24026704645699 K993194 000
24026704645682 K993194 000
24026704645668 K993194 000
24026704645651 K993194 000
24026704645644 K993194 000
24026704645675 K993194 000
B0024050UP3 K993194 000
B0024025UP3 K993194 000
B0024010UP3 K993194 000
B0024000UP3 K993194 000
B0024000F0 K993194 000
B00240000 K993194 000
B0024000U0 K993194 000
00627843557562 K993194 000
00627843557555 K993194 000
00627843557548 K993194 000
00627843557531 K993194 000
00627843557524 K993194 000
B0024050U3 K993194 000
B00240506 K993194 000
B0024025U0 K993194 000
B00240256 K993194 000
B0024010U3 K993194 000
B00240100 K993194 000
B0024050RB7 K993194 000

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