The following data is part of a premarket notification filed by External Counterpulsation Lab with the FDA for Aecp-a, Automatic External Counterpulsation Device.
| Device ID | K012141 |
| 510k Number | K012141 |
| Device Name: | AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE |
| Classification | Device, Counter-pulsating, External |
| Applicant | EXTERNAL COUNTERPULSATION LAB BEIT HAPA'AMON (BOX 124) 20 HATA'AS ST. Kfar Saba, IL 44425 |
| Contact | Ahava Stein |
| Correspondent | Ahava Stein EXTERNAL COUNTERPULSATION LAB BEIT HAPA'AMON (BOX 124) 20 HATA'AS ST. Kfar Saba, IL 44425 |
| Product Code | DRN |
| CFR Regulation Number | 870.5225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-10 |
| Decision Date | 2001-10-25 |