The following data is part of a premarket notification filed by Echocath, Inc. with the FDA for Echomark(r) Electrophysiology Catheter.
| Device ID | K933417 |
| 510k Number | K933417 |
| Device Name: | ECHOMARK(R) ELECTROPHYSIOLOGY CATHETER |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| 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 | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-13 |
| Decision Date | 1995-05-04 |