The following data is part of a premarket notification filed by Astro-med, Inc. with the FDA for K3 System.
| Device ID | K934644 |
| 510k Number | K934644 |
| Device Name: | K3 SYSTEM |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | ASTRO-MED, INC. 600 EAST GREENWICH AVE. West Warwick, RI 02893 |
| Contact | Michael Sullivan |
| Correspondent | Michael Sullivan ASTRO-MED, INC. 600 EAST GREENWICH AVE. West Warwick, RI 02893 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-29 |
| Decision Date | 1994-11-01 |