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 Amplifier, Physiological Signal
510(k) Number K052060
Device Name OPTI-AMP DC-POWERED
Applicant
INTELLIGENT HEARING SYSTEMS
7356 S.W. 48 ST.
MIAMI,  FL  33155
Applicant Contact EDWARD MISKIEL
Correspondent
INTELLIGENT HEARING SYSTEMS
7356 S.W. 48 ST.
MIAMI,  FL  33155
Correspondent Contact EDWARD MISKIEL
Regulation Number882.1835
Classification Product Code
GWL  
Date Received07/29/2005
Decision Date 08/31/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-