The following data is part of a premarket notification filed by Cambridge Heart, Inc. with the FDA for Cambridge Heart Oem.
| Device ID | K100362 |
| 510k Number | K100362 |
| Device Name: | CAMBRIDGE HEART OEM |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | CAMBRIDGE HEART, INC. 20310 SW 48TH ST. Southwest Ranches, FL 33332 |
| Contact | John Greenbaum |
| Correspondent | John Greenbaum CAMBRIDGE HEART, INC. 20310 SW 48TH ST. Southwest Ranches, FL 33332 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-12 |
| Decision Date | 2010-04-14 |
| Summary: | summary |