DOPPLER NEEDLE AND FLOW MONITOR
FDA 510(k) clearance K903625 · decided 1990-11-07
Clearance details
- K-number
- K903625
- Device name
- DOPPLER NEEDLE AND FLOW MONITOR
- Applicant
- Peripheral Systems Group
- Decision
- Substantially Equivalent
- Date received
- 1990-08-10
- Decision date
- 1990-11-07
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- DPW
- Device class
- 2
- Regulation number
- 870.2100
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| PD Access Vascular Access Device. Escalon Vascular Access, Inc., 2440 South 179th Street, recall (Z-0132-2011) | Escalon Medical Corp | 2010-10-22 |