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510(k) K831008

Device
HEAD STRAP
Applicant
MEDOVATIONS, INC.
510(k) number
K831008
Product code
BTK  
Decision
Substantially Equivalent (SESE)
Decision date
1983-05-09
Date received
1983-03-30
Regulation
868.5560
Classification name
Strap, Head, Gas Mask
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BTK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K944949GENERAL ANESTHESIA SYSTEMVital Signs, Inc.1994-11-14
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
K810991HEADSTRAPRespironics, Inc.1981-04-29

Legacy Summary#

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FDA Review#

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