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 gas-machine, anesthesia
510(k) Number K970163
Device Name ALPHA MX (20)/ULTRA PC (30)
Applicant
TECHNICAL MEDICAL PRODUCTS, INC.
2020 WEST MELINDA LN.
PHOENIX,  AZ  85027
Applicant Contact JIM R MOORE
Correspondent
TECHNICAL MEDICAL PRODUCTS, INC.
2020 WEST MELINDA LN.
PHOENIX,  AZ  85027
Correspondent Contact JIM R MOORE
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received01/16/1997
Decision Date 12/10/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-