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510(k) K935126

Device
NASCOR IGLOO
Applicant
NASCOR PTY. LTD.
510(k) number
K935126
Product code
BYL  
Decision
Substantially Equivalent (SESE)
Decision date
1994-10-18
Date received
1993-10-28
Regulation
868.5700
Classification name
Tent, Oxygen
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
HOWARD CHILTON, M.D.
Address
P.O. Box 141 Beverly Hills Nsw Sydney Nsw AU 2209 2209

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BYL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K905627NASCOR OXYDOMENascor Pty. , Ltd.1991-06-03
K896608SPAG PAKViratek, Inc.1990-04-09
K895866DIRD INGANT O2 (BIO 2 HOOD)Bird Products Corp.1989-10-27
K893713NOVA OXYGEN TENTNova Health Systems, Inc.1989-08-21
K893714KEYSTONE OXYGEN TENTKeystone Veterinary Supplies, Inc.1989-08-21
K882396AEROSOL DELIVERY HOODViratek, Inc.1988-08-01
K851666MEDI-COMP NEONATAL OXYGEN HOODMedicomp, Inc.1985-08-06
K852345SEA-LONG NECKSEAL & HOODSafety Sea Systems, Inc.1985-06-20
K820640HOO2D SEAT-INFANTDhd Medical Products Div. Diemolding Corp.1982-03-26
K802653MEDIUM SIZE OXYGEN HOOD #1547Ann Arbor Plastics, Inc.1980-11-24

Legacy Summary#

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FDA Review#

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