The following data is part of a premarket notification filed by Future Impex Corp. with the FDA for Model {m-102 I-channel Electro Cardiograph Unit.
| Device ID | K843934 |
| 510k Number | K843934 |
| Device Name: | MODEL {M-102 I-CHANNEL ELECTRO CARDIOGRAPH UNIT |
| Classification | Electrocardiograph |
| Applicant | FUTURE IMPEX CORP. 2076 DEER PARK AVE. Deerpark, NY 11729 |
| Contact | Morad Davoudzadeh |
| Correspondent | Morad Davoudzadeh FUTURE IMPEX CORP. 2076 DEER PARK AVE. Deerpark, 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 | 1984-10-09 |
| Decision Date | 1984-11-20 |