The following data is part of a premarket notification filed by Arzco Medical Electronics, Inc. with the FDA for Arzo Tapcath Esophageal Recording Catheter.
| Device ID | K903136 |
| 510k Number | K903136 |
| Device Name: | ARZO TAPCATH ESOPHAGEAL RECORDING CATHETER |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | ARZCO MEDICAL ELECTRONICS, INC. 1029 BUTTERFIELD RD. (DUPLICATE/1927197) Vernon Hills, IL 60061 |
| Contact | Frank Goldberg |
| Correspondent | Frank Goldberg ARZCO MEDICAL ELECTRONICS, INC. 1029 BUTTERFIELD RD. (DUPLICATE/1927197) Vernon Hills, IL 60061 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-17 |
| Decision Date | 1991-01-18 |