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, External Body, Negative Pressure, Adult (Cuirass)
510(k) Number K902300
Device Name EASY BREATHER MODEL 100 ACCESSORIES
Applicant
Progressive Productions , Ltd.
70 Archwood Dr.
Mohrsville,  PA  19541
Applicant Contact M BOGUSKY
Correspondent
Progressive Productions , Ltd.
70 Archwood Dr.
Mohrsville,  PA  19541
Correspondent Contact M BOGUSKY
Regulation Number868.5935
Classification Product Code
BYT  
Date Received05/23/1990
Decision Date 07/19/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-