SYMPHONY METER REMOTE
FDA 510(k) clearance K082590 · decided 2008-12-17
Clearance details
- K-number
- K082590
- Device name
- SYMPHONY METER REMOTE
- Applicant
- Lifescan, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-09-08
- Decision date
- 2008-12-17
- Days to decision
- 100 days
- Clearance type
- Traditional
- Product code
- LZG
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Milpitas, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.