The following data is part of a premarket notification filed by Cadwell Industries, Inc. with the FDA for Cadwell Ampliscan.
| Device ID | K161027 |
| 510k Number | K161027 |
| Device Name: | Cadwell AmpliScan |
| Classification | Amplitude-integrated Electroencephalograph |
| Applicant | Cadwell Industries, Inc. 909 N. Kellog St. Kennewick, WA 99336 |
| Contact | John Cadwell |
| Correspondent | John Cadwell Cadwell Industries, Inc. 909 N. Kellog St. Kennewick, WA 99336 |
| Product Code | OMA |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-12 |
| Decision Date | 2016-11-08 |
| Summary: | summary |