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 device, positive pressure breathing, intermittent
510(k) Number K151689
Device Name MetaNeb 4 System
Applicant
Hill-Rom Services Pte Ltd
1 Yishun Ave 7
Singapore,  SG 768923
Applicant Contact Huifang Zhu
Correspondent
Hill-Rom Services Pte Ltd
1 Yishun Ave 7
Singapore,  SG 768923
Correspondent Contact Paul Dryden
Regulation Number868.5905
Classification Product Code
NHJ  
Date Received06/23/2015
Decision Date 03/17/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-