FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INFUSION DYNAMICS POWER INFUSER
K Number: K974074
·
Decision Feb 17, 1998
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
34
Applicant Total
3
Review Days
111
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
- INFUSION DYNAMICS POWER INFUSER
- K Number
- K974074
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5420
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Infusion Dynamics, Inc.
- Date Received
- October 29, 1997
- Decision Date
- February 17, 1998
- 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.
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
ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000
FDA 510(k)
FDA Class 1
·General Hospital