GENERAL ANESTHESIA SYSTEM

Strap, Head, Gas Mask

VITAL SIGNS, INC.

The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for General Anesthesia System.

Pre-market Notification Details

Device IDK944949
510k NumberK944949
Device Name:GENERAL ANESTHESIA SYSTEM
ClassificationStrap, Head, Gas Mask
Applicant VITAL SIGNS, INC. 20 CAMPUS RD. Totowa,  NJ  07512
ContactJing Zhang
CorrespondentJing Zhang
VITAL SIGNS, INC. 20 CAMPUS RD. Totowa,  NJ  07512
Product CodeBTK  
CFR Regulation Number868.5560 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-10-07
Decision Date1994-11-14

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