The following data is part of a premarket notification filed by Compass Intl., Inc. with the FDA for Regulus Navigator.
| Device ID | K964229 |
| 510k Number | K964229 |
| Device Name: | REGULUS NAVIGATOR |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | COMPASS INTL., INC. 919 37TH AVE., N.W., CASCADE BUSINESS PARK Rochester, MN 55901 |
| Contact | Debrah A Fisher |
| Correspondent | Debrah A Fisher COMPASS INTL., INC. 919 37TH AVE., N.W., CASCADE BUSINESS PARK Rochester, MN 55901 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-23 |
| Decision Date | 1997-08-19 |
| Summary: | summary |