The following data is part of a premarket notification filed by Cleveland Medical Devices, Inc. with the FDA for Crystal Monitor Model 16.
| Device ID | K013863 |
| 510k Number | K013863 |
| Device Name: | CRYSTAL MONITOR MODEL 16 |
| Classification | Reduced- Montage Standard Electroencephalograph |
| Applicant | CLEVELAND MEDICAL DEVICES, INC. 11000 CEDAR AVE., SUITE 130 Cleveland, OH 44106 |
| Contact | Robert N Schmidt |
| Correspondent | Robert N Schmidt CLEVELAND MEDICAL DEVICES, INC. 11000 CEDAR AVE., SUITE 130 Cleveland, OH 44106 |
| Product Code | OMC |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-21 |
| Decision Date | 2002-02-19 |
| Summary: | summary |