• 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 attachment, breathing, positive end expiratory pressure
510(k) Number K081266
Device Name MERCURY MEDICAL PEEP VALVE
Applicant
MERCURY ENTERPRIZES DBA MERCURY MEDICAL
11300 49TH STREET NORTH
CLEARWATER,  FL  33762
Applicant Contact BRIAN L MORRISON
Correspondent
MERCURY ENTERPRIZES DBA MERCURY MEDICAL
11300 49TH STREET NORTH
CLEARWATER,  FL  33762
Correspondent Contact BRIAN L MORRISON
Regulation Number868.5965
Classification Product Code
BYE  
Date Received05/05/2008
Decision Date 03/05/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-