FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MONITOR, NON-INVASIVE BLOOD PRESSURE
K Number: K782000
·
Decision Dec 5, 1978
Classifications
1
FEI Numbers
428
Registration Numbers
428
Same Product Code
1216
Applicant Total
2
Review Days
13
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Basic Information
- Device Name
- MONITOR, NON-INVASIVE BLOOD PRESSURE
- K Number
- K782000
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Automated Screening Devices
- Date Received
- November 22, 1978
- Decision Date
- December 5, 1978
- Product Code
- DXN
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | FDA class 2 | Cardiovascular |
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Other Clearances by Automated Screening Devices
| K Number | Device Name | ||
|---|---|---|---|
| K792653 | SENTRY | Jan 4, 1980 | Substantially Equivalent |