The following data is part of a premarket notification filed by S-tct Health Inc. with the FDA for External Counterpulsation (ecp) Model Us-ecp.
| Device ID | K030587 |
| 510k Number | K030587 |
| Device Name: | EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP |
| Classification | Device, Counter-pulsating, External |
| Applicant | S-TCT HEALTH INC. 2020 PONCE DE LEON BLVD., SUITE 1101 Coral Gables, FL 33134 |
| Contact | Katherine L Giannamore |
| Correspondent | Katherine L Giannamore S-TCT HEALTH INC. 2020 PONCE DE LEON BLVD., SUITE 1101 Coral Gables, FL 33134 |
| Product Code | DRN |
| CFR Regulation Number | 870.5225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-25 |
| Decision Date | 2003-05-30 |
| Summary: | summary |