The following data is part of a premarket notification filed by Future Impex Corp. with the FDA for Erma Hb-meter Model 303n.
| Device ID | K854687 |
| 510k Number | K854687 |
| Device Name: | ERMA HB-METER MODEL 303N |
| Classification | Whole Blood Hemoglobin Determination |
| 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 | KHG |
| CFR Regulation Number | 864.7500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-20 |
| Decision Date | 1986-06-04 |