The following data is part of a premarket notification filed by Cambridge Heart, Inc. with the FDA for Cambridge Heart Ch 2000 Stress Test System.
Device ID | K950018 |
510k Number | K950018 |
Device Name: | CAMBRIDGE HEART CH 2000 STRESS TEST SYSTEM |
Classification | Electrocardiograph |
Applicant | CAMBRIDGE HEART, INC. ONE OAK PARK DR. Bedford, MA 01730 |
Contact | M Arie |
Correspondent | M Arie CAMBRIDGE HEART, INC. ONE OAK PARK DR. Bedford, MA 01730 |
Product Code | DPS |
CFR Regulation Number | 870.2340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-01-03 |
Decision Date | 1996-02-29 |