The following data is part of a premarket notification filed by Kay Elemetrics Corp. with the FDA for Digital Video Recording System.
Device ID | K991738 |
510k Number | K991738 |
Device Name: | DIGITAL VIDEO RECORDING SYSTEM |
Classification | System, Image Processing, Radiological |
Applicant | KAY ELEMETRICS CORP. 2 BRIDGEWATER LN. Lincoln Park, NJ 07035 -1488 |
Contact | William D Harbeson |
Correspondent | William D Harbeson KAY ELEMETRICS CORP. 2 BRIDGEWATER LN. Lincoln Park, NJ 07035 -1488 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-05-21 |
Decision Date | 1999-08-13 |