FDA.reportPublic FDA data

510(k) K953506

Device
WESTMED RESPIRATORY LUER ADAPTOR
Applicant
WESTMED INTL.
510(k) number
K953506
Product code
BXY  
Decision
Substantially Equivalent (SESE)
Decision date
1995-09-15
Date received
1995-07-26
Regulation
868.2350
Classification name
Flowmeter, Calibration, Gas
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
LYNN D HAYSE
Address
3351 E. Hemisphere Loop Tucson AZ US 85706 85706

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code BXY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K902916PRECISION MEDICAL NEB BLOCKPrecision Medical, Inc.1990-07-23
K902917PRECISION MEDICAL ELIMINATORPrecision Medical, Inc.1990-07-23
K863510OXY-OFF(TM)B&B Medical Technologies, Inc.1986-10-22
K860516LSP MINILATORLife Support Products, Inc.1986-02-21
K851460NEW CONNECTOR & COVER FOR TELECTRONICS 8MM UNIPOLATelectronics, Inc.1985-05-10
K781523PFT GASESGardner Cryogenics1978-12-01

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