The following data is part of a premarket notification filed by St. Jude Medical, Mediguide Navigation Systems with the FDA for Mediguide Technology.
| Device ID | K120301 |
| 510k Number | K120301 |
| Device Name: | MEDIGUIDE TECHNOLOGY |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | ST. JUDE MEDICAL, MEDIGUIDE NAVIGATION SYSTEMS COLUMBIA SQUARE 555 THIRTEENTH, NW Washington, DC 20004 -1109 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan ST. JUDE MEDICAL, MEDIGUIDE NAVIGATION SYSTEMS COLUMBIA SQUARE 555 THIRTEENTH, NW Washington, DC 20004 -1109 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-31 |
| Decision Date | 2012-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067020550 | K120301 | 000 |
| 05415067012135 | K120301 | 000 |
| 05415067010933 | K120301 | 000 |
| 05415067009807 | K120301 | 000 |
| 05415067009791 | K120301 | 000 |
| 05415067006752 | K120301 | 000 |
| 05415067006721 | K120301 | 000 |
| 05415067006714 | K120301 | 000 |
| 05415067006707 | K120301 | 000 |
| 05415067006691 | K120301 | 000 |
| 05415067006684 | K120301 | 000 |
| 05415067004697 | K120301 | 000 |
| 05415067004680 | K120301 | 000 |
| 05415067004604 | K120301 | 000 |
| 05415067004314 | K120301 | 000 |
| 05415067004307 | K120301 | 000 |
| 05415067012555 | K120301 | 000 |
| 05415067012562 | K120301 | 000 |
| 05415067012579 | K120301 | 000 |
| 05415067020512 | K120301 | 000 |
| 05415067020505 | K120301 | 000 |
| 05415067020499 | K120301 | 000 |
| 05415067020482 | K120301 | 000 |
| 05415067020475 | K120301 | 000 |
| 05415067020468 | K120301 | 000 |
| 05415067018519 | K120301 | 000 |
| 05415067018038 | K120301 | 000 |
| 05415067016256 | K120301 | 000 |
| 05415067016249 | K120301 | 000 |
| 05415067014672 | K120301 | 000 |
| 05415067013279 | K120301 | 000 |
| 05415067013262 | K120301 | 000 |
| 05415067013002 | K120301 | 000 |
| 05415067012586 | K120301 | 000 |
| 15415067000719 | K120301 | 000 |