SMART LABEL, PROPOFOL
FDA 510(k) clearance K142333 · decided 2014-12-18
Clearance details
- K-number
- K142333
- Device name
- SMART LABEL, PROPOFOL
- Applicant
- American I.V. Products, Inc. Dba Aiv, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-08-21
- Decision date
- 2014-12-18
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- MRZ
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Harmans, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.