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 Device, Biofeedback
510(k) Number K971708
Device Name PHYSIOLOGICAL MONITORING & BIOFEEDBACK TRAINING DEVICE
Applicant
J & J ENGINEERING, INC.
55 NORTHERN BLVD., SUITE 410
GREAT NECK,  NY  11021
Applicant Contact ANAND AKERKAR
Correspondent
J & J ENGINEERING, INC.
55 NORTHERN BLVD., SUITE 410
GREAT NECK,  NY  11021
Correspondent Contact ANAND AKERKAR
Regulation Number882.5050
Classification Product Code
HCC  
Date Received05/08/1997
Decision Date 02/18/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-