MMC AMPLIFIER
FDA 510(k) clearance K943673 · decided 1994-10-26
Clearance details
- K-number
- K943673
- Device name
- MMC AMPLIFIER
- Applicant
- Melville Software , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1994-07-26
- Decision date
- 1994-10-26
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- GWL
- Device class
- 2
- Regulation number
- 882.1835
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Ottawa, Ontario, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.