The following data is part of a premarket notification filed by Damon Corp. with the FDA for Damon D.e.t.e.c.t Image Enhancer.
Device ID | K874865 |
510k Number | K874865 |
Device Name: | DAMON D.E.T.E.C.T IMAGE ENHANCER |
Classification | System, Image Processing, Radiological |
Applicant | DAMON CORP. 45 WEST ST. SUITE 2 Attleboro, MA 02703 |
Contact | James R Veale |
Correspondent | James R Veale DAMON CORP. 45 WEST ST. SUITE 2 Attleboro, MA 02703 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-27 |
Decision Date | 1987-12-23 |