ALLON 2000
FDA 510(k) clearance K992386 · decided 2000-03-07
Clearance details
- K-number
- K992386
- Device name
- ALLON 2000
- Applicant
- Mtre Advanced Technology , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1999-07-16
- Decision date
- 2000-03-07
- Days to decision
- 235 days
- Clearance type
- Traditional
- Product code
- DWJ
- Device class
- 2
- Regulation number
- 870.5900
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Ra'Ananna 43373, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.