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, Non-Direct Patient Interface (Home-Use)
510(k) Number K862919
Device Name TRANSPIRATOR(TM) MT-1000 PERSONAL HUMIDIFIER
Applicant
Transpirator Technologics, Inc.
265 Davidson Ave.
Somerset,  NJ  08873
Applicant Contact JOHN E PORCELLA
Correspondent
Transpirator Technologics, Inc.
265 Davidson Ave.
Somerset,  NJ  08873
Correspondent Contact JOHN E PORCELLA
Regulation Number868.5460
Classification Product Code
KFZ  
Date Received08/01/1986
Decision Date 11/07/1986
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
-
-