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 Calculator, Pulmonary Function Data
510(k) Number K011344
Device Name INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400
Applicant
COLLINS MEDICAL, INC.
555 THIRTEENTH ST. NW
WASHINGTON,  DC  20004 -1109
Applicant Contact JONATHAN S KAHAN
Correspondent
COLLINS MEDICAL, INC.
555 THIRTEENTH ST. NW
WASHINGTON,  DC  20004 -1109
Correspondent Contact JONATHAN S KAHAN
Regulation Number868.1880
Classification Product Code
BZC  
Subsequent Product Codes
BZG   CCM  
Date Received05/02/2001
Decision Date 05/17/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
-
-