• 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 K150685
FOIA Releasable 510(k) K150685
Device Name Skynector CPAP Mask
Applicant
SKY WISE MEDICAL INSTRUMENT (SHEN ZHEN) CO., LTD.
NO.12 SOUTH PING XI RD
XINSHENG COMMUNITY, LONGGANG ST. LONGGANG DIST
SHENZHEN, GUANG DONG,  CN 518110
Applicant Contact Field Fu
Correspondent
SKY WISE MEDICAL INSTRUMENT (SHEN ZHEN) CO., LTD.
NO.12 SOUTH PING XI RD
XINSHENG COMMUNITY, LONGGANG ST. LONGGANG DIST
SHENZHEN, GUANG DONG,  CN 518110
Correspondent Contact Field Fu
Regulation Number868.5905
Classification Product Code
BZD  
Date Received03/17/2015
Decision Date 08/24/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-