The following data is part of a premarket notification filed by Compass Intl., Inc. with the FDA for Regulus Measurement Unit.
| Device ID | K935456 |
| 510k Number | K935456 |
| Device Name: | REGULUS MEASUREMENT UNIT |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | COMPASS INTL., INC. CASCADE BUSINESS PARK 919 37TH AVENUE, N.W. Rochester, MN 55901 |
| Contact | Bruce A Kall |
| Correspondent | Bruce A Kall COMPASS INTL., INC. CASCADE BUSINESS PARK 919 37TH AVENUE, N.W. 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 | 1993-11-12 |
| Decision Date | 1995-10-13 |