The following data is part of a premarket notification filed by Radiometer America, Inc. with the FDA for Microbact 12a System, 12b System, And 24e System.
| Device ID | K912444 |
| 510k Number | K912444 |
| Device Name: | MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM |
| Classification | Chamber, Patient Isolation |
| Applicant | RADIOMETER AMERICA, INC. 811 SHARON DR. Westlake, OH 44145 -1598 |
| Contact | Kathleen M Ontko |
| Correspondent | Kathleen M Ontko RADIOMETER AMERICA, INC. 811 SHARON DR. Westlake, OH 44145 -1598 |
| Product Code | LGM |
| CFR Regulation Number | 880.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-03 |
| Decision Date | 1992-02-18 |