The following data is part of a premarket notification filed by Atomic Products Corp. with the FDA for Digital Image Enhancement System.
Device ID | K900851 |
510k Number | K900851 |
Device Name: | DIGITAL IMAGE ENHANCEMENT SYSTEM |
Classification | System, Image Processing, Radiological |
Applicant | ATOMIC PRODUCTS CORP. P.O. DRAWER R Shirley, NY 11967 |
Contact | Clyde Schlein |
Correspondent | Clyde Schlein ATOMIC PRODUCTS CORP. P.O. DRAWER R Shirley, NY 11967 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-02-22 |
Decision Date | 1990-05-11 |