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 monitor, airway pressure (includes gauge and/or alarm)
510(k) Number K122627
Device Name GIO DIGITAL PRESSURE GUAGES
Applicant
GALEMED CORP.
29201 VIA NORTE
TEMECULA,  CA  92591
Applicant Contact TOM SHANKS
Correspondent
GALEMED CORP.
29201 VIA NORTE
TEMECULA,  CA  92591
Correspondent Contact TOM SHANKS
Regulation Number868.2600
Classification Product Code
CAP  
Date Received08/28/2012
Decision Date 08/22/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-