The following data is part of a premarket notification filed by Northern Digital, Inc. with the FDA for Ndi Passive Spheres.
| Device ID | K033621 |
| 510k Number | K033621 |
| Device Name: | NDI PASSIVE SPHERES |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | NORTHERN DIGITAL, INC. 4 INNOVATION DRIVE Dundas, Ontario, CA L9h 7p3 |
| Contact | Nancy Ruth |
| Correspondent | Nancy Ruth NORTHERN DIGITAL, INC. 4 INNOVATION DRIVE Dundas, Ontario, CA L9h 7p3 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-18 |
| Decision Date | 2004-01-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00805832070043 | K033621 | 000 |
| 00805832020024 | K033621 | 000 |
| 00805832020031 | K033621 | 000 |
| 20805832020042 | K033621 | 000 |
| 20805832030010 | K033621 | 000 |
| 20805832030027 | K033621 | 000 |
| 20805832030034 | K033621 | 000 |
| 20805832030041 | K033621 | 000 |
| 20805832040019 | K033621 | 000 |
| 20805832040026 | K033621 | 000 |
| 20805832040033 | K033621 | 000 |
| 20805832070016 | K033621 | 000 |
| 20805832070023 | K033621 | 000 |
| 20805832070030 | K033621 | 000 |
| 00805832020017 | K033621 | 000 |