FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CORRECT FLO INTRAVASCULAR ADMINISTRATION SET
K Number: K850506
·
Decision Apr 1, 1985
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
10
Review Days
52
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Basic Information
- Device Name
- CORRECT FLO INTRAVASCULAR ADMINISTRATION SET
- K Number
- K850506
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Biomedical Dynamics, Inc.
- Date Received
- February 8, 1985
- Decision Date
- April 1, 1985
- Product Code
- FPA
- 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
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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 |
| K911216 | INFUSABLE | Jul 22, 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 |