The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Q5000 Pc Workstation.
Device ID | K892113 |
510k Number | K892113 |
Device Name: | Q5000 PC WORKSTATION |
Classification | Computer, Diagnostic, Programmable |
Applicant | QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
Contact | Ron R Duck |
Correspondent | Ron R Duck QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
Product Code | DQK |
CFR Regulation Number | 870.1425 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-03-13 |
Decision Date | 1989-05-18 |