The following data is part of a premarket notification filed by Cpca2000 Inc with the FDA for Cpca2000 Counterpulsation System.
| Device ID | K030532 |
| 510k Number | K030532 |
| Device Name: | CPCA2000 COUNTERPULSATION SYSTEM |
| Classification | Device, Counter-pulsating, External |
| Applicant | CPCA2000 INC 6336 17TH ST. CIRCLE EAST Sarasota, FL 34243 |
| Contact | Rod Shipman |
| Correspondent | Rod Shipman CPCA2000 INC 6336 17TH ST. CIRCLE EAST Sarasota, FL 34243 |
| Product Code | DRN |
| CFR Regulation Number | 870.5225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-19 |
| Decision Date | 2003-03-14 |
| Summary: | summary |