The following data is part of a premarket notification filed by Cadwell Laboratories, Inc. with the FDA for Ees 10 Electrodeless Electrical Stimulator.
Device ID | K863175 |
510k Number | K863175 |
Device Name: | EES 10 ELECTRODELESS ELECTRICAL STIMULATOR |
Classification | Stimulator, Electrical, Evoked Response |
Applicant | CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST. Kennewick, WA 99336 |
Contact | Cadwell, Dds |
Correspondent | Cadwell, Dds CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST. Kennewick, WA 99336 |
Product Code | GWF |
CFR Regulation Number | 882.1870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-08-18 |
Decision Date | 1987-01-13 |