IMPULSE 6000D/7000DP

Tester, Defibrillator

FLUKE BIOMEDICAL

The following data is part of a premarket notification filed by Fluke Biomedical with the FDA for Impulse 6000d/7000dp.

Pre-market Notification Details

Device IDK072114
510k NumberK072114
Device Name:IMPULSE 6000D/7000DP
ClassificationTester, Defibrillator
Applicant FLUKE BIOMEDICAL 1717 WEST COLLINS AVE. Orange,  CA  92867
ContactColleen Boswell
CorrespondentColleen Boswell
FLUKE BIOMEDICAL 1717 WEST COLLINS AVE. Orange,  CA  92867
Product CodeDRL  
CFR Regulation Number870.5325 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-08-01
Decision Date2008-01-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850540007119 K072114 000

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