The following data is part of a premarket notification filed by Mckenna & Cuneo with the FDA for Dantec Keypoint.
Device ID | K944547 |
510k Number | K944547 |
Device Name: | DANTEC KEYPOINT |
Classification | Stimulator, Electrical, Evoked Response |
Applicant | MCKENNA & CUNEO 1575 EYE ST. N.W. Washington, DC 20005 |
Contact | Richard D Manthei |
Correspondent | Richard D Manthei MCKENNA & CUNEO 1575 EYE ST. N.W. Washington, DC 20005 |
Product Code | GWF |
CFR Regulation Number | 882.1870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-09-15 |
Decision Date | 1995-09-19 |
Summary: | summary |