The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Resubmitted Excalibur.
Device ID | K880271 |
510k Number | K880271 |
Device Name: | RESUBMITTED EXCALIBUR |
Classification | Exerciser, Measuring |
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 | ISD |
CFR Regulation Number | 890.5360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-01-21 |
Decision Date | 1988-02-03 |