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 |