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 Oximeter
510(k) Number K011365
Device Name VITALSAT PULSE OXIMETER, MODEL IC32000
Applicant
ISLAND CRITICAL CARE CORP.
9 MYRTLE ST.
STRATFORD, P.E.I.,  CA C1B 1P4
Applicant Contact SEAN FLANIGAN
Correspondent
ISLAND CRITICAL CARE CORP.
9 MYRTLE ST.
STRATFORD, P.E.I.,  CA C1B 1P4
Correspondent Contact SEAN FLANIGAN
Regulation Number870.2700
Classification Product Code
DQA  
Date Received05/04/2001
Decision Date 10/26/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-