MEDIX PHOTOTHERAPY LAMP
FDA 510(k) clearance K931965 · decided 1993-12-09
Clearance details
- K-number
- K931965
- Device name
- MEDIX PHOTOTHERAPY LAMP
- Applicant
- Medix I.C.S.A.
- Decision
- Substantially Equivalent
- Date received
- 1993-04-22
- Decision date
- 1993-12-09
- Days to decision
- 231 days
- Clearance type
- Traditional
- Product code
- LBI
- Device class
- 2
- Regulation number
- 880.5700
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- San Martin, Buenos Aires, AR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.