MANTRA COMBO, MODEL MECS 320
FDA 510(k) clearance K091236 · decided 2009-07-30
Clearance details
- K-number
- K091236
- Device name
- MANTRA COMBO, MODEL MECS 320
- Applicant
- Mantra Intl. (Hk) , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2009-04-27
- Decision date
- 2009-07-30
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- GZJ
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Oxford, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.