EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACK

Pump, Infusion

SIMS DELTEC, INC.

The following data is part of a premarket notification filed by Sims Deltec, Inc. with the FDA for External Power Source (eps) System, Power Pack.

Pre-market Notification Details

Device IDK960957
510k NumberK960957
Device Name:EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACK
ClassificationPump, Infusion
Applicant SIMS DELTEC, INC. 1265 GREY FOX RD. St. Paul,  MN  55112
ContactDavid H Short
CorrespondentDavid H Short
SIMS DELTEC, INC. 1265 GREY FOX RD. St. Paul,  MN  55112
Product CodeFRN  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-03-11
Decision Date1996-06-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00610586017004 K960957 000
00610586016977 K960957 000
00610586016960 K960957 000
10610586017018 K960957 000
10610586016998 K960957 000
10610586016981 K960957 000

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