FDA.reportPublic FDA data

510(k) K970046

Device
UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1550)
Applicant
ACCUTRON, INC.
510(k) number
K970046
Product code
KHA  
Decision
Substantially Equivalent (SESE)
Decision date
1997-03-28
Date received
1997-01-06
Regulation
868.5590
Classification name
Mask, Scavenging
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JAMES R MOORE
Address
2020 W. Melinda Ln. Phoenix AZ US 85027 85027

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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