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 |