Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Mask, Scavenging
510(k) Number K970046
Device Name UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1550)
Applicant
ACCUTRON, INC.
2020 WEST MELINDA LN.
PHOENIX,  AZ  85027
Applicant Contact JAMES R MOORE
Correspondent
ACCUTRON, INC.
2020 WEST MELINDA LN.
PHOENIX,  AZ  85027
Correspondent Contact JAMES R MOORE
Regulation Number868.5590
Classification Product Code
KHA  
Date Received01/06/1997
Decision Date 03/28/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-