EL2-SERIES BLOOD COLLECTION REERVOIR

Reservoir, Blood, Cardiopulmonary Bypass

ELECTROMEDICS, INC.

The following data is part of a premarket notification filed by Electromedics, Inc. with the FDA for El2-series Blood Collection Reervoir.

Pre-market Notification Details

Device IDK930154
510k NumberK930154
Device Name:EL2-SERIES BLOOD COLLECTION REERVOIR
ClassificationReservoir, Blood, Cardiopulmonary Bypass
Applicant ELECTROMEDICS, INC. 7337 SOUTH REVERE PKWY. Englewood,  CO  80112
ContactHarold W Bryan
CorrespondentHarold W Bryan
ELECTROMEDICS, INC. 7337 SOUTH REVERE PKWY. Englewood,  CO  80112
Product CodeDTN  
CFR Regulation Number870.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-01-13
Decision Date1993-07-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20613994842910 K930154 000
20613994842903 K930154 000

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