Critical Measurement Unit
FDA 510(k) K822556 · Bemis Health Care
510(k) numberK822556
Submission
- Device name
- Critical Measurement Unit
- Applicant
- Bemis Health Care
Mchenry, IL, US - Received
- August 24, 1982
- Decision date
- October 18, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BYZ – Trap, Sterile Specimen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6740
- Specialty
- General Hospital
Other 510(k)s with product code BYZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K925412 | Electromedics Tissue Trap/ #TT280BYZ · Traditional | Electromedics, Inc. | 02/05/1993SE |
| K913643 | Mucous Specimen TrapBYZ · Traditional | Medical Device Inspection Co., Inc. | 10/10/1991SE |
| K902883 | Tissue/Polyp Trap SystemBYZ · Traditional | Triton Technology, Inc. | 09/12/1990SE |
| K841409 | Bush Neck W/PlugBYZ · Traditional | Warne Surgical Products, Ltd. | 04/18/1984SE |
| K840253 | One-Way Air ValveBYZ · Traditional | Delta Medical Industries | 04/05/1984SE |
| K834467 | Specimen TrapBYZ · Traditional | Microvasive | 02/17/1984SE |
| K822557 | Specimen AdaptorBYZ · Traditional | Bemis Health Care | 10/18/1982SE |
| K791847 | Aspri-LukeBYZ · Traditional | Medical Marketing Group | 10/02/1979SE |
More from Medical Marketing Group
| 510(k) | Device | Decision |
|---|---|---|
| K885019 | Bemis Sterile-Case for Use W/Ethylene Oxide Steri.FRG · Traditional | 01/25/1989SE |
| K822557 | Specimen AdaptorBYZ · Traditional | 10/18/1982SE |
| K803206 | Suction ProbeJOL · Traditional | 01/21/1981SE |
| K771737 | Suction CanisterGCX · Traditional | 12/20/1977SE |
| K771738 | Male UrinalFNP · Traditional | 09/28/1977SE |
| K771733 | 8 Emesis BasinFNY · Traditional | 09/28/1977SE |
| K760393 | Bed Pan, Stackable (Autoclavable)FOB · Traditional | 08/23/1976SE |
| K760073 | Basin, Wash, 6-QT RectangularLDQ · Traditional | 07/20/1976SE |
| K760072 | Carafe, Personal, 1-QT Semi-Rectangular · Traditional | 07/20/1976SE |
| K760071 | Tray, Personal, Rectang. 8 1/2 X 5 1/4 · Traditional | 07/20/1976SE |
Questions and answers
When was Critical Measurement Unit cleared by the FDA?
Critical Measurement Unit (K822556) received a 510(k) decision of Substantially Equivalent on October 18, 1982, 55 days after the submission was received.
What is the product code of K822556?
The FDA product code is BYZ – Trap, Sterile Specimen, a Class II (moderate risk) device regulated under 21 CFR 880.6740.