FDA.reportPublic FDA data

510(k) K896608

Device
SPAG PAK
Applicant
VIRATEK, INC.
510(k) number
K896608
Product code
BYL  
Decision
Substantially Equivalent (SESE)
Decision date
1990-04-09
Date received
1989-11-21
Regulation
868.5700
Classification name
Tent, Oxygen
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ALICE M WEI
Address
Icn Plz. 3300 Hyland Ave. Costa Mesa CA US 92626 92626

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
K935126NASCOR IGLOONascor Pty. , Ltd.1994-10-18
K905627NASCOR OXYDOMENascor Pty. , Ltd.1991-06-03
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#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases