The following data is part of a premarket notification filed by Cleveland Medical Devices, Inc. with the FDA for Crystal-eeg Model 10 (model 10).
| Device ID | K970672 |
| 510k Number | K970672 |
| Device Name: | CRYSTAL-EEG MODEL 10 (MODEL 10) |
| Classification | Reduced- Montage Standard Electroencephalograph |
| Applicant | CLEVELAND MEDICAL DEVICES, INC. 11000 CEDAR AVE. SUITE 439 Cleveland, OH 44106 |
| Contact | Robert N Schmidt |
| Correspondent | Robert N Schmidt CLEVELAND MEDICAL DEVICES, INC. 11000 CEDAR AVE. SUITE 439 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 | 1997-02-24 |
| Decision Date | 1997-05-22 |
| Summary: | summary |