MODEL PV2000 VASCULAR MICROLABORATORY
FDA 510(k) clearance K951486 · decided 1995-06-29
Clearance details
- K-number
- K951486
- Device name
- MODEL PV2000 VASCULAR MICROLABORATORY
- Applicant
- Vasamedics, LLC
- Decision
- Substantially Equivalent
- Date received
- 1995-03-30
- Decision date
- 1995-06-29
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- DPW
- Device class
- 2
- Regulation number
- 870.2100
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Saint Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.