OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330
FDA 510(k) clearance K020335 · decided 2002-06-18
Clearance details
- K-number
- K020335
- Device name
- OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330
- Applicant
- Olympic Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-02-01
- Decision date
- 2002-06-18
- Days to decision
- 137 days
- Clearance type
- Traditional
- Product code
- OMC
- Device class
- 2
- Regulation number
- 882.1400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Seattle, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.