FDA 510(k) Application Details - K100233

Device Classification Name Device, Galvanic Skin Response Measurement

  More FDA Info for this Device
510(K) Number K100233
Device Name Device, Galvanic Skin Response Measurement
Applicant IMPETO MEDICAL
4479 SHOREPOINTS WAY
SAN DIEGO, CA 92130 US
Other 510(k) Applications for this Company
Contact KYE CHEUNG
Other 510(k) Applications for this Contact
Regulation Number 882.1540

  More FDA Info for this Regulation Number
Classification Product Code GZO
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 01/26/2010
Decision Date 06/14/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact