The following data is part of a premarket notification filed by Cadwell Industries, Inc. with the FDA for Cadwell Bolt Software.
| Device ID | K190760 |
| 510k Number | K190760 |
| Device Name: | Cadwell Bolt Software |
| Classification | Non-normalizing Quantitative Electroencephalograph Software |
| Applicant | Cadwell Industries, Inc. 909 N. Kellogg Street Kennewick, WA 99336 |
| Contact | Emily Whitehead |
| Correspondent | Emily Whitehead Cadwell Industries, Inc. 909 N. Kellogg Street Kennewick, WA 99336 |
| Product Code | OLT |
| Subsequent Product Code | OMA |
| Subsequent Product Code | ORT |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-25 |
| Decision Date | 2019-11-23 |