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, Non-Continuous (Respirator)
510(k) Number K021534
Device Name IQ NASAL MASK, MODEL 50160 REV. D
Applicant
Sleepnet Corporation
1050 Perimeter Rd.,
Lockheed Air Center
Manchester,  NH  03103
Applicant Contact PAUL R CHIESA
Correspondent
Sleepnet Corporation
1050 Perimeter Rd.,
Lockheed Air Center
Manchester,  NH  03103
Correspondent Contact PAUL R CHIESA
Regulation Number868.5905
Classification Product Code
BZD  
Date Received05/10/2002
Decision Date 07/02/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-