FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CRITICAL MEASUREMENT UNIT
K Number: K822556
·
Decision Oct 18, 1982
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
8
Applicant Total
12
Review Days
55
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CRITICAL MEASUREMENT UNIT
- K Number
- K822556
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Bemis Health Care
- Date Received
- August 24, 1982
- Decision Date
- October 18, 1982
- Product Code
- BYZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BYZ | Trap, Sterile Specimen | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BYZ), ordered by most recent decision date.
ELECTROMEDICS TISSUE TRAP/ #TT280
FDA 510(k)
FDA Class 2
·General Hospital
MUCOUS SPECIMEN TRAP
FDA 510(k)
FDA Class 2
·General Hospital
TISSUE/POLYP TRAP SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
BUSH NECK W/PLUG
FDA 510(k)
FDA Class 2
·General Hospital
ONE-WAY AIR VALVE
FDA 510(k)
FDA Class 2
·General Hospital
SPECIMEN TRAP
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Bemis Health Care
| K Number | Device Name | ||
|---|---|---|---|
| K885019 | BEMIS STERILE-CASE FOR USE W/ETHYLENE OXIDE STERI. | Jan 25, 1989 | Substantially Equivalent |
| K822557 | SPECIMEN ADAPTOR | Oct 18, 1982 | Substantially Equivalent |
| K803206 | SUCTION PROBE | Jan 21, 1981 | Substantially Equivalent |
| K771737 | SUCTION CANISTER | Dec 20, 1977 | Substantially Equivalent |
| K771738 | MALE URINAL | Sep 28, 1977 | Substantially Equivalent |
| K771733 | 8 EMESIS BASIN | Sep 28, 1977 | Substantially Equivalent |
| K760393 | BED PAN, STACKABLE (AUTOCLAVABLE) | Aug 23, 1976 | Substantially Equivalent |
| K760071 | TRAY, PERSONAL, RECTANG. 8 1/2 X 5 1/4 | Jul 20, 1976 | Substantially Equivalent |
| K760070 | TUMBLER, PERSONAL, ROUND, 9 OUNCE | Jul 20, 1976 | Substantially Equivalent |
| K760073 | BASIN, WASH, 6-QT RECTANGULAR | Jul 20, 1976 | Substantially Equivalent |