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510(k) K941547

Device
CAM 4 THERMOELECTRIC CHILD/ADULT MIST TENT
Applicant
ALLIED HEALTHCARE PRODUCTS, INC.
510(k) number
K941547
Product code
BYK  
Decision
Substantially Equivalent (SESE)
Decision date
1995-03-01
Date received
1994-03-30
Regulation
868.5710
Classification name
Tent, Oxygen, Electrically Powered
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
WAYNE KARCHER
Address
1720 Sublette Ave. Saint Louis MO US 63110 63110

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BYK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K882817LUNG DIFFUSION GAS MIXTURESwisco, Inc.1988-08-15
K813235DISS FEMALE AIR ADAPTORTimeter Instrument Corp.1981-12-08

Legacy Summary#

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FDA Review#

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