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510(k) K944949

Device
GENERAL ANESTHESIA SYSTEM
Applicant
VITAL SIGNS, INC.
510(k) number
K944949
Product code
BTK  
Decision
Substantially Equivalent - Kit (SESK)
Decision date
1994-11-14
Date received
1994-10-07
Regulation
868.5560
Classification name
Strap, Head, Gas Mask
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JING ZHANG
Address
20 Campus Rd. Totowa NJ US 07512 07512

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code BTK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K914335STRAP, HEAD, GAS MASKVital Signs, Inc.1992-04-02
K854537HEADSTRAPLife Design Systems, Inc.1985-12-03
K853573MEDIPART FACE MASK HEADSTRAP MP-9100Medipart Jerry Alexander1985-10-29
K831008HEAD STRAPMedovations, Inc.1983-05-09
K810991HEADSTRAPRespironics, Inc.1981-04-29

Legacy Summary#

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FDA Review#

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