MEDVIZERTM VITELCARE PATIENT MONITORING SYSTEM
FDA 510(k) clearance K040581 · decided 2004-05-27
Clearance details
- K-number
- K040581
- Device name
- MEDVIZERTM VITELCARE PATIENT MONITORING SYSTEM
- Applicant
- Vitel Net
- Decision
- Substantially Equivalent
- Date received
- 2004-03-04
- Decision date
- 2004-05-27
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- DQA
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mclean, VA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.