The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Quinton Q.cath.
Device ID | K862740 |
510k Number | K862740 |
Device Name: | QUINTON Q.CATH |
Classification | Computer, Diagnostic, Programmable |
Applicant | QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
Contact | Donald L Andersen |
Correspondent | Donald L Andersen 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 | 1986-07-21 |
Decision Date | 1986-10-31 |