The following data is part of a premarket notification filed by Washington Biolab, Inc. with the FDA for Washington Cardiac Monitor.
| Device ID | K903710 |
| 510k Number | K903710 |
| Device Name: | WASHINGTON CARDIAC MONITOR |
| Classification | Echocardiograph |
| Applicant | WASHINGTON BIOLAB, INC. P.O. BOX 1182 Ames, IA 50010 |
| Contact | Ki, Ph.d. |
| Correspondent | Ki, Ph.d. WASHINGTON BIOLAB, INC. P.O. BOX 1182 Ames, IA 50010 |
| Product Code | DXK |
| CFR Regulation Number | 870.2330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-14 |
| Decision Date | 1990-11-09 |