The following data is part of a premarket notification filed by Bemis Health Care with the FDA for Critical Measurement Unit.
| Device ID | K822556 |
| 510k Number | K822556 |
| Device Name: | CRITICAL MEASUREMENT UNIT |
| Classification | Trap, Sterile Specimen |
| Applicant | BEMIS HEALTH CARE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BYZ |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-24 |
| Decision Date | 1982-10-18 |