FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NORFOLK/NORWICH PRESSURE INFUSION BOX
K Number: K810954
·
Decision Apr 21, 1981
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
34
Applicant Total
24
Review Days
14
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
- NORFOLK/NORWICH PRESSURE INFUSION BOX
- K Number
- K810954
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5420
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Medical Innovations Corp.
- Date Received
- April 7, 1981
- Decision Date
- April 21, 1981
- Product Code
- KZD
- 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 |
|---|---|---|---|
| KZD | Infusor, Pressure, For I.V. Bags | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KZD), ordered by most recent decision date.
INFUSION DYNAMICS POWER INFUSER
FDA 510(k)
FDA Class 1
·General Hospital
MSI PRESSURE INFUSOR
FDA 510(k)
FDA Class 1
·General Hospital
OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP
FDA 510(k)
FDA Class 1
·General Hospital
PRESSURIZER
FDA 510(k)
FDA Class 1
·General Hospital
PRESSURE INFUSION CUFF
FDA 510(k)
FDA Class 1
·General Hospital
KAWASUMI LABORATORIES K-CUFF
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Medical Innovations Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K945612 | MIC NASOGASTRIC-GASTROJEJUNAL FEEDING TUBE | Apr 19, 1995 | Substantially Equivalent |
| K940548 | MIC PERCUTANEOUS ENDOSCOPIC JEJUNAL FEEDING TUBE | Feb 22, 1995 | Substantially Equivalent |
| K943685 | MIC DISPOSABLE SNARE | Nov 1, 1994 | Substantially Equivalent |
| K926581 | MIC TRANSGASTRIC JEJUNAL TUBE | Sep 28, 1994 | Substantially Equivalent |
| K921652 | MIC TRANSGASTRIC JEJUNAL FEEDING TUBE KIT | May 2, 1994 | Unknown |
| K921370 | MIC GASTRO-ENTEROSTOMY TUBE MODIFICATION | May 2, 1994 | Unknown |
| K924065 | MIC PEG TUBE | Feb 17, 1994 | Unknown |
| K922667 | MIC LOW PROFILE GASTROSTOMY TUBE | Dec 1, 1993 | Unknown |
| K913320 | MIL CM-II COAGULATION MACHINE | Jun 16, 1992 | Substantially Equivalent |
| K903531 | ANTICARDIOLIPIN ANTIBODY TEST SYSTEM | Jan 25, 1991 | Substantially Equivalent |