The following data is part of a premarket notification filed by Cambridge Heart, Inc. with the FDA for Cambridge Heart Hi-res Ecg Electrode.
| Device ID | K962115 |
| 510k Number | K962115 |
| Device Name: | CAMBRIDGE HEART HI-RES ECG ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | CAMBRIDGE HEART, INC. ONE OAK PARK DR. Bedford, MA 01730 |
| Contact | Robert T Miragliuolo |
| Correspondent | Robert T Miragliuolo CAMBRIDGE HEART, INC. ONE OAK PARK DR. Bedford, MA 01730 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-31 |
| Decision Date | 1996-08-29 |
| Summary: | summary |