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 Neurological Stereotaxic Instrument
510(k) Number K022074
Device Name SPHERZ
Applicant
I.Z.I. CORP.
7020 TUDSBURY RD.
BALTIMORE,  MD  21244
Applicant Contact HELEN ZINREICH
Correspondent
I.Z.I. CORP.
7020 TUDSBURY RD.
BALTIMORE,  MD  21244
Correspondent Contact HELEN ZINREICH
Regulation Number882.4560
Classification Product Code
HAW  
Date Received06/26/2002
Decision Date 08/13/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-