INFANT/PEDIATRIC RESUSCITATION CIRCUIT W/APL

Ventilator, Non-continuous (respirator)

VITAL SIGNS, INC.

The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Infant/pediatric Resuscitation Circuit W/apl.

Pre-market Notification Details

Device IDK911465
510k NumberK911465
Device Name:INFANT/PEDIATRIC RESUSCITATION CIRCUIT W/APL
ClassificationVentilator, Non-continuous (respirator)
Applicant VITAL SIGNS, INC. 20 CAMPUS RD. Totowa,  NJ  07512
ContactAlberto Velez
CorrespondentAlberto Velez
VITAL SIGNS, INC. 20 CAMPUS RD. Totowa,  NJ  07512
Product CodeBZD  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-04-03
Decision Date1991-10-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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30889483586505 K911465 000
30889483586475 K911465 000
30889483586451 K911465 000
30889483586444 K911465 000
30889483586406 K911465 000

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