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 K133769
Device Name 3B RESMART BPAP 25A, BMC RESMART BPAP 25A
Applicant
3B Medical, Inc.
21301 Hwy 27 N
Lake Wales,  FL  33859
Applicant Contact ALEX LUCIO
Correspondent
3B Medical, Inc.
21301 Hwy 27 N
Lake Wales,  FL  33859
Correspondent Contact ALEX LUCIO
Regulation Number868.5905
Classification Product Code
BZD  
Date Received12/11/2013
Decision Date 08/25/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-