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 spirometer, monitoring (w/wo alarm)
510(k) Number K863866
Device Name RESPIRADYNE II(TM)
Applicant
CHESEBROUGH-POND'S U.S.A. CO.
TRUMBULL INDUSTRIAL PARK
TRUMBULL,  CT  06611
Applicant Contact RONALD E MCCARLEY
Correspondent
CHESEBROUGH-POND'S U.S.A. CO.
TRUMBULL INDUSTRIAL PARK
TRUMBULL,  CT  06611
Correspondent Contact RONALD E MCCARLEY
Regulation Number868.1850
Classification Product Code
BZK  
Date Received10/03/1986
Decision Date 01/28/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-