MEASURED VOLUME SOLUTION ADMINISTRATION SET
FDA 510(k) clearance K940054 · decided 1994-04-15
Clearance details
- K-number
- K940054
- Device name
- MEASURED VOLUME SOLUTION ADMINISTRATION SET
- Applicant
- Puritas Health Care, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-01-05
- Decision date
- 1994-04-15
- Days to decision
- 100 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- New Milford, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.