The following data is part of a premarket notification filed by Keta Corp. with the FDA for Quantum 412.
Device ID | K844570 |
510k Number | K844570 |
Device Name: | QUANTUM 412 |
Classification | Perimeter, Automatic, Ac-powered |
Applicant | KETA CORP. 9 CANAL ST. Danvers, MA 01923 |
Contact | Kenneth P Taylor |
Correspondent | Kenneth P Taylor KETA CORP. 9 CANAL ST. Danvers, MA 01923 |
Product Code | HPT |
CFR Regulation Number | 886.1605 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-11-23 |
Decision Date | 1984-12-05 |