The following data is part of a premarket notification filed by Cherne Industries, Inc. with the FDA for Modified Cherne Cad Detector.
| Device ID | K860015 |
| 510k Number | K860015 |
| Device Name: | MODIFIED CHERNE CAD DETECTOR |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | CHERNE INDUSTRIES, INC. 5701 SOUTH COUNTY RD. 18 Minneapolis, MN 55436 |
| Contact | Mark W Kroll |
| Correspondent | Mark W Kroll CHERNE INDUSTRIES, INC. 5701 SOUTH COUNTY RD. 18 Minneapolis, MN 55436 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-03 |
| Decision Date | 1986-04-23 |