LUMIN
FDA 510(k) clearance K943448 · decided 1995-04-11
Clearance details
- K-number
- K943448
- Device name
- LUMIN
- Applicant
- Utah Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-07-18
- Decision date
- 1995-04-11
- Days to decision
- 267 days
- Clearance type
- Traditional
- Product code
- LKF
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Midvale, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.