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 ventilatory effort recorder
510(k) Number K013905
Device Name MODIFICATION EZ-1 SYSTEM REPIRATORY SENSORS
Applicant
PRO-TECH SERVICES, INC.
4338 HARBOUR POINTE BLVD. S.W.
MUKILTEO,  WA  98275
Applicant Contact NEIL SHELLER
Correspondent
PRO-TECH SERVICES, INC.
4338 HARBOUR POINTE BLVD. S.W.
MUKILTEO,  WA  98275
Correspondent Contact NEIL SHELLER
Regulation Number868.2375
Classification Product Code
MNR  
Date Received11/26/2001
Decision Date 04/22/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
-
-