The following data is part of a premarket notification filed by Western Graphtec with the FDA for Wr3500 And Wr3600 Series Recorders.
Device ID | K894922 |
510k Number | K894922 |
Device Name: | WR3500 AND WR3600 SERIES RECORDERS |
Classification | Recorder, Paper Chart |
Applicant | WESTERN GRAPHTEC 11 VANDERBILT ST. Irvine, CA 92618 -2067 |
Contact | Jim Craig |
Correspondent | Jim Craig WESTERN GRAPHTEC 11 VANDERBILT ST. Irvine, CA 92618 -2067 |
Product Code | DSF |
CFR Regulation Number | 870.2810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-08-02 |
Decision Date | 1990-01-26 |