The following data is part of a premarket notification filed by Transfer Technology with the FDA for Pro-tech Delivery System Electrodes, Model Tt-2000.
| Device ID | K081279 |
| 510k Number | K081279 |
| Device Name: | PRO-TECH DELIVERY SYSTEM ELECTRODES, MODEL TT-2000 |
| Classification | Electrode, Cutaneous |
| Applicant | TRANSFER TECHNOLOGY 37822 OXFORD DRIVE Murrieta, CA 92562 |
| Contact | Joseph J Arbour |
| Correspondent | Joseph J Arbour TRANSFER TECHNOLOGY 37822 OXFORD DRIVE Murrieta, CA 92562 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-06 |
| Decision Date | 2009-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B1870532 | K081279 | 000 |
| B1870522 | K081279 | 000 |
| B1870192 | K081279 | 000 |