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 |