FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ANEROID BLOOD PRESSURE GAUGE
K Number: K904376
·
Decision Dec 20, 1990
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
2
Applicant Total
10
Review Days
86
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Basic Information
- Device Name
- ANEROID BLOOD PRESSURE GAUGE
- K Number
- K904376
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Biomedical Dynamics, Inc.
- Date Received
- September 25, 1990
- Decision Date
- December 20, 1990
- Product Code
- FCY
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FCY | Bulb, Inflation, For Endoscope | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FCY), ordered by most recent decision date.
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FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
TRANS/R - FP(3)
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
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 |
| 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 |