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 Humidifier, Respiratory Gas, (Direct Patient Interface)
510(k) Number K902970
Device Name PRECISION MEDICAL DISPOSABLE HUMIDIFIER
Applicant
Precision Medical, Inc.
7285 Park Dr.
Bath,  PA  18014
Applicant Contact JOHN R SELADY
Correspondent
Precision Medical, Inc.
7285 Park Dr.
Bath,  PA  18014
Correspondent Contact JOHN R SELADY
Regulation Number868.5450
Classification Product Code
BTT  
Date Received07/06/1990
Decision Date 08/14/1990
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
-
-