The following data is part of a premarket notification filed by Living Data Technologies Corporation with the FDA for Mobile External Counter Pulsation System Angionew-v.
| Device ID | K033657 |
| 510k Number | K033657 |
| Device Name: | MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V |
| Classification | Device, Counter-pulsating, External |
| Applicant | LIVING DATA TECHNOLOGIES CORPORATION 55 NORTHERN BLVD. SUITE 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk LIVING DATA TECHNOLOGIES CORPORATION 55 NORTHERN BLVD. SUITE 200 Great Neck, NY 11021 |
| Product Code | DRN |
| CFR Regulation Number | 870.5225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-21 |
| Decision Date | 2003-12-19 |
| Summary: | summary |