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 K902764
Device Name EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARM
Applicant
J. H. Emerson Co.
22 Cottage Park Ave.
Cambridge,  MA  02140
Applicant Contact GEORGE P EMERSON
Correspondent
J. H. Emerson Co.
22 Cottage Park Ave.
Cambridge,  MA  02140
Correspondent Contact GEORGE P EMERSON
Regulation Number868.5935
Classification Product Code
BYT  
Date Received06/25/1990
Decision Date 11/19/1990
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
-
-