The following data is part of a premarket notification filed by Diros Technology, Inc. with the FDA for Owl Rf Probes.
| Device ID | K110593 |
| 510k Number | K110593 |
| Device Name: | OWL RF PROBES |
| Classification | Probe, Radiofrequency Lesion |
| Applicant | DIROS TECHNOLOGY, INC. 232 HOOD ROAD Markham, Ontario, CA L3r 3k8 |
| Contact | George Darmos |
| Correspondent | George Darmos DIROS TECHNOLOGY, INC. 232 HOOD ROAD Markham, Ontario, CA L3r 3k8 |
| Product Code | GXI |
| CFR Regulation Number | 882.4725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-02 |
| Decision Date | 2011-05-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00825114006317 | K110593 | 000 |
| 825114001770 | K110593 | 000 |
| 00825114001749 | K110593 | 000 |
| 00825114001756 | K110593 | 000 |
| 00825114001763 | K110593 | 000 |
| 00825114006249 | K110593 | 000 |
| 00825114006256 | K110593 | 000 |
| 00825114006263 | K110593 | 000 |
| 00825114006270 | K110593 | 000 |
| 00825114006287 | K110593 | 000 |
| 00825114006294 | K110593 | 000 |
| 00825114006300 | K110593 | 000 |
| 00825114001770 | K110593 | 000 |