FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INFUSABLE
K Number: K911216
·
Decision Jul 22, 1991
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
34
Applicant Total
10
Review Days
125
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Basic Information
- Device Name
- INFUSABLE
- K Number
- K911216
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5420
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Biomedical Dynamics, Inc.
- Date Received
- March 19, 1991
- Decision Date
- July 22, 1991
- 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 Biomedical Dynamics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K915074 | IRRIGATOR/ASPIRATOR PROBE | Feb 5, 1992 | Substantially Equivalent |
| K913751 | PRESSURE INFUSER | Jan 9, 1992 | Substantially Equivalent |
| K911213 | CUFFABLE | Aug 7, 1991 | Substantially Equivalent |
| K911324 | IRRIGATION/ASPIRATION TUBING SET | Jun 24, 1991 | Substantially Equivalent |
| K904376 | ANEROID BLOOD PRESSURE GAUGE | Dec 20, 1990 | Substantially Equivalent |
| K890268 | PRESSURE INFUSOR FOR I.V. BAGS/AUTOINFLATION | May 5, 1989 | Substantially Equivalent |
| K881799 | BLOOD PRESSURE CUFF | Oct 14, 1988 | Substantially Equivalent |
| K861977 | BIOMEDICAL DYNAMICS DISPOSABLE PRESSURE INFUSOR | Jul 15, 1986 | Substantially Equivalent |
| K850506 | CORRECT FLO INTRAVASCULAR ADMINISTRATION SET | Apr 1, 1985 | Substantially Equivalent |