The following data is part of a premarket notification filed by Artel, Inc. with the FDA for Hbm Hemoglobinometer.
| Device ID | K933836 |
| 510k Number | K933836 |
| Device Name: | HBM HEMOGLOBINOMETER |
| Classification | Hemoglobinometer |
| Applicant | ARTEL, INC. 12 DEPOT ST. Windham, ME 04062 |
| Contact | Charles Ewing |
| Correspondent | Charles Ewing ARTEL, INC. 12 DEPOT ST. Windham, ME 04062 |
| Product Code | GIG |
| CFR Regulation Number | 864.7500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-05 |
| Decision Date | 1994-03-31 |