FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DYNAPULSE 500G (DP500G) BLLOD PRESSURE MONITORING SYSTEM
K Number: K012498
·
Decision Nov 1, 2001
Classifications
1
FEI Numbers
428
Registration Numbers
428
Same Product Code
1216
Applicant Total
5
Review Days
90
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Basic Information
- Device Name
- DYNAPULSE 500G (DP500G) BLLOD PRESSURE MONITORING SYSTEM
- K Number
- K012498
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pulse Metric, Inc.
- Date Received
- August 3, 2001
- Decision Date
- November 1, 2001
- 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 Pulse Metric, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K013478 | DYNAPULSE 5200A PATHWAY BLOOD PRESSURE MONITORING SYSTEM | Jan 10, 2002 | Substantially Equivalent |
| K013358 | DYNAPULSE 5000A MINI ABP BLOOD PRESSURE MONITORING SYSTEM | Dec 13, 2001 | Substantially Equivalent |
| K945111 | DYNAPULSE 5000A (DP5000A) | Jun 23, 1995 | Substantially Equivalent |
| K904739 | DYNAPULSE 200M | Jan 8, 1991 | Substantially Equivalent |