The following data is part of a premarket notification filed by Danam Electronics with the FDA for Danam Vector-8+.
Device ID | K892205 |
510k Number | K892205 |
Device Name: | DANAM VECTOR-8+ |
Classification | Counter, Differential Cell |
Applicant | DANAM ELECTRONICS 4230 SHILLING WAY Dallas, TX 75237 |
Contact | Jerry B West |
Correspondent | Jerry B West DANAM ELECTRONICS 4230 SHILLING WAY Dallas, TX 75237 |
Product Code | GKZ |
CFR Regulation Number | 864.5220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-03 |
Decision Date | 1989-06-13 |