MINI-LOGGER SERIES 2000
FDA 510(k) clearance K991045 · decided 1999-09-21
Clearance details
- K-number
- K991045
- Device name
- MINI-LOGGER SERIES 2000
- Applicant
- Mini-Mitter Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-03-29
- Decision date
- 1999-09-21
- Days to decision
- 176 days
- Clearance type
- Traditional
- Product code
- GWK
- Device class
- 2
- Regulation number
- 882.1845
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Sunriver, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.