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 K013486
Device Name VAPOTHERM 2000H
Applicant
VAPOTHERM, INC.
6329 W.WATERVIEW CT.
MCCORDSVILLE,  IN  46055 -9501
Applicant Contact PAUL E DRYDEN
Correspondent
VAPOTHERM, INC.
6329 W.WATERVIEW CT.
MCCORDSVILLE,  IN  46055 -9501
Correspondent Contact PAUL E DRYDEN
Regulation Number868.5450
Classification Product Code
BTT  
Subsequent Product Codes
BTI   BZR  
Date Received10/19/2001
Decision Date 05/30/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-