The following data is part of a premarket notification filed by Applied Cardiac Systems with the FDA for Acs Model Ncp-2.
| Device ID | K042413 |
| 510k Number | K042413 |
| Device Name: | ACS MODEL NCP-2 |
| Classification | Device, Counter-pulsating, External |
| Applicant | APPLIED CARDIAC SYSTEMS 22912 EL PACIFICO DR. Laguna Hills, CA 92653 |
| Contact | R. Ben Ghadimi |
| Correspondent | R. Ben Ghadimi APPLIED CARDIAC SYSTEMS 22912 EL PACIFICO DR. Laguna Hills, CA 92653 |
| Product Code | DRN |
| CFR Regulation Number | 870.5225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-07 |
| Decision Date | 2004-12-09 |
| Summary: | summary |