The following data is part of a premarket notification filed by Echocath, Inc. with the FDA for Colormark(tm) Visualization System.
| Device ID | K926351 |
| 510k Number | K926351 |
| Device Name: | COLORMARK(TM) VISUALIZATION SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | ECHOCATH, INC. P.O. BOX 7224 Princeton, NJ 08543 -7224 |
| Contact | Frank Debernardis |
| Correspondent | Frank Debernardis ECHOCATH, INC. P.O. BOX 7224 Princeton, NJ 08543 -7224 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-17 |
| Decision Date | 1993-09-16 |