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 humidifier, respiratory gas, (direct patient interface)
510(k) Number K131957
Device Name MR810RESPIRATORY HUMIDIFIER, 900MR810 ADULT SINGLE LIMB CIRCUIT, 900MR810E ADULT DUAL LIMB CIRCUIT
Applicant
FISHER & PAYKEL HEALTHCARE, LTD.
15 MAURICE PAYKEL PLACE
EAST TAMAKI
ACKLAND,  NZ 2013
Applicant Contact ELIZABETH GOLDSTEIN
Correspondent
FISHER & PAYKEL HEALTHCARE, LTD.
15 MAURICE PAYKEL PLACE
EAST TAMAKI
ACKLAND,  NZ 2013
Correspondent Contact ELIZABETH GOLDSTEIN
Regulation Number868.5450
Classification Product Code
BTT  
Date Received06/27/2013
Decision Date 12/04/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-