The following data is part of a premarket notification filed by Ohio Medical Instrument Co., Inc. with the FDA for Mayfield Acciss Optical System.
| Device ID | K982244 |
| 510k Number | K982244 |
| Device Name: | MAYFIELD ACCISS OPTICAL SYSTEM |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | OHIO MEDICAL INSTRUMENT CO., INC. 4900 CHARLEMAR DR. Cincinnati, OH 45227 |
| Contact | Kenneth Miller |
| Correspondent | Kenneth 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 | 1998-06-25 |
| Decision Date | 1998-09-23 |
| Summary: | summary |