The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Hemoglobinometer.
| Device ID | K832288 |
| 510k Number | K832288 |
| Device Name: | HEMOGLOBINOMETER |
| Classification | Purifier, Water, Ultraviolet, Medical |
| Applicant | MALLINCKRODT CRITICAL CARE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KMG |
| CFR Regulation Number | 880.6710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-13 |
| Decision Date | 1983-09-01 |