VITALMAX 530
FDA 510(k) clearance K932203 · decided 1994-07-19
Clearance details
- K-number
- K932203
- Device name
- VITALMAX 530
- Applicant
- Pace Tech Medical Monitors, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-05-06
- Decision date
- 1994-07-19
- Days to decision
- 439 days
- Clearance type
- Traditional
- Product code
- DQA
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Clearwater, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.