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 |