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 ventilator, continuous, facility use
510(k) Number K063806
Device Name SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTED
Applicant
SLEEPNET CORPORATION
1050 PERIMETER RD.
MANCHESTER AIR CENTER
MANCHESTER,  NH  03103
Applicant Contact PAUL CHIESA
Correspondent
SLEEPNET CORPORATION
1050 PERIMETER RD.
MANCHESTER AIR CENTER
MANCHESTER,  NH  03103
Correspondent Contact PAUL CHIESA
Regulation Number868.5895
Classification Product Code
CBK  
Date Received12/22/2006
Decision Date 05/17/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-