The following data is part of a premarket notification filed by Futuremed Div. Of Future Impex Corp. with the FDA for Futuremed Ecg System 500.
| Device ID | K862381 |
| 510k Number | K862381 |
| Device Name: | FUTUREMED ECG SYSTEM 500 |
| Classification | Electrocardiograph |
| Applicant | FUTUREMED DIV. OF FUTURE IMPEX CORP. 2076 DEER PARK AVE. Deer Park, NY 11729 |
| Contact | Morad Davoudzadeh |
| Correspondent | Morad Davoudzadeh FUTUREMED DIV. OF FUTURE IMPEX CORP. 2076 DEER PARK AVE. Deer Park, NY 11729 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-24 |
| Decision Date | 1986-07-17 |