The following data is part of a premarket notification filed by Ohio Medical Instrument Co., Inc. with the FDA for The Mayfield / Acciss System With Windows Nt For Cranial Surgery, The Mayfield / Optical Acciss System With Windows Nt F.
| Device ID | K992843 |
| 510k Number | K992843 |
| Device Name: | THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT F |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | OHIO MEDICAL INSTRUMENT CO., INC. 4900 CHARLEMAR DR. Cincinnati, OH 45227 |
| Contact | Kenneth B Miller |
| Correspondent | Kenneth B Miller OHIO MEDICAL INSTRUMENT CO., INC. 4900 CHARLEMAR DR. Cincinnati, OH 45227 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-24 |
| Decision Date | 1999-11-02 |
| Summary: | summary |