The following data is part of a premarket notification filed by Radionics, A Division Of Tyco Healthcare Group Lp with the FDA for Modification To Optical Tracking System (ots).
| Device ID | K010548 |
| 510k Number | K010548 |
| Device Name: | MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP 22 TERRY AVE. Burlington, MA 01803 |
| Contact | Kevin J O'connell |
| Correspondent | Kevin J O'connell RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP 22 TERRY AVE. Burlington, MA 01803 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-26 |
| Decision Date | 2001-03-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M433OS71001 | K010548 | 000 |
| M433OS40021 | K010548 | 000 |
| M433OS40031 | K010548 | 000 |
| M433OS41101 | K010548 | 000 |
| M248MRCTF21 | K010548 | 000 |
| 30381780252874 | K010548 | 000 |
| M433ST10021 | K010548 | 000 |
| M433OTDRFNI1 | K010548 | 000 |
| M433RB1 | K010548 | 000 |
| M433ST10001 | K010548 | 000 |
| M248OTDB1 | K010548 | 000 |
| M433OS40011 | K010548 | 000 |