The following data is part of a premarket notification filed by Medical Rescue Equipment Holding As with the FDA for Infu Box Type 0412a.
| Device ID | K120860 |
| 510k Number | K120860 |
| Device Name: | INFU BOX TYPE 0412A |
| Classification | Warmer, Thermal, Infusion Fluid |
| Applicant | MEDICAL RESCUE EQUIPMENT HOLDING AS POSTBOKS 186 Porsgrunn, NO 3901 |
| Contact | Knut Fangberget |
| Correspondent | Knut Fangberget MEDICAL RESCUE EQUIPMENT HOLDING AS POSTBOKS 186 Porsgrunn, NO 3901 |
| Product Code | LGZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-22 |
| Decision Date | 2012-05-08 |
| Summary: | summary |