CRITERION, CRITERION I.V., MODIFIED
FDA 510(k) clearance K952267 · decided 1997-12-02
Clearance details
- K-number
- K952267
- Device name
- CRITERION, CRITERION I.V., MODIFIED
- Applicant
- Nova-Ventrx
- Decision
- Substantially Equivalent
- Date received
- 1995-05-15
- Decision date
- 1997-12-02
- Days to decision
- 932 days
- Clearance type
- Traditional
- Product code
- BZE
- Device class
- 2
- Regulation number
- 868.5270
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Northbrook, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.