The following data is part of a premarket notification filed by Cambridge Heart, Inc. with the FDA for Cambridge Heart Micro-v Alternans Sensor, Model 20327-002.
| Device ID | K002230 |
| 510k Number | K002230 |
| Device Name: | CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002 |
| Classification | Electrode, Electrocardiograph |
| Applicant | CAMBRIDGE HEART, INC. 20310 SW 48TH ST. Ft. Lauderdale, FL 33332 |
| Contact | John Greenbaum |
| Correspondent | John Greenbaum CAMBRIDGE HEART, INC. 20310 SW 48TH ST. Ft. Lauderdale, FL 33332 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-24 |
| Decision Date | 2000-08-18 |