The following data is part of a premarket notification filed by Stony Brook Trading And Development Corp. with the FDA for Stony Brook Model Eecp-mc1.
| Device ID | K882401 |
| 510k Number | K882401 |
| Device Name: | STONY BROOK MODEL EECP-MC1 |
| Classification | Device, Counter-pulsating, External |
| Applicant | STONY BROOK TRADING AND DEVELOPMENT CORP. 25 ASHAROKEN AVE. Northport, NY 11766 |
| Contact | Hui, Phd |
| Correspondent | Hui, Phd STONY BROOK TRADING AND DEVELOPMENT CORP. 25 ASHAROKEN AVE. Northport, NY 11766 |
| Product Code | DRN |
| CFR Regulation Number | 870.5225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-10 |
| Decision Date | 1989-03-03 |