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 Electrode, Cutaneous
510(k) Number K092828
Device Name STATNET, MODEL 3100
Applicant
Hydrodot, Inc.
238 Littleton Rd.
Suite 202
Westford,  MA  01886
Applicant Contact KATHLEEN PRINCIPE
Correspondent
Hydrodot, Inc.
238 Littleton Rd.
Suite 202
Westford,  MA  01886
Correspondent Contact KATHLEEN PRINCIPE
Regulation Number882.1320
Classification Product Code
GXY  
Date Received09/14/2009
Decision Date 01/29/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-