The following data is part of a premarket notification filed by Digitimer Ltd. with the FDA for Ds7a Constant Current High Voltage Stimulator, Model Ds7a; Ds7ah Constant Current High Voltage Stimulator, Model Ds7ah.
| Device ID | K051357 |
| 510k Number | K051357 |
| Device Name: | DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A; DS7AH CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7AH |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | DIGITIMER LTD. ONE EAST BROWARD BOULEVARD SUITE 700 Fort Lauderdale, FL 33301 |
| Contact | Harry J Benedict |
| Correspondent | Harry J Benedict DIGITIMER LTD. ONE EAST BROWARD BOULEVARD SUITE 700 Fort Lauderdale, FL 33301 |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-24 |
| Decision Date | 2005-09-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060490360010 | K051357 | 000 |
| 05060490360003 | K051357 | 000 |