The following data is part of a premarket notification filed by Astro-med, Inc. with the FDA for Dash Iv.
Device ID | K912929 |
510k Number | K912929 |
Device Name: | DASH IV |
Classification | Recorder, Paper Chart |
Applicant | ASTRO-MED, INC. 600 EAST GREENWICH AVE. West Warwick, RI 02893 |
Contact | Donna J Ray |
Correspondent | Donna J Ray ASTRO-MED, INC. 600 EAST GREENWICH AVE. West Warwick, RI 02893 |
Product Code | DSF |
CFR Regulation Number | 870.2810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-07-05 |
Decision Date | 1991-08-13 |