The following data is part of a premarket notification filed by Burke Neutech, Inc. with the FDA for Neuro-aide.
Device ID | K942926 |
510k Number | K942926 |
Device Name: | NEURO-AIDE |
Classification | Pinwheel |
Applicant | BURKE NEUTECH, INC. 11701 S. BELCHER RD. SUITE 119 Largo, FL 34643 -5117 |
Contact | Robert E Burke |
Correspondent | Robert E Burke BURKE NEUTECH, INC. 11701 S. BELCHER RD. SUITE 119 Largo, FL 34643 -5117 |
Product Code | GWY |
CFR Regulation Number | 882.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-06-22 |
Decision Date | 1994-08-03 |