OLYMPIC CFM 6000
FDA 510(k) clearance K031149 · decided 2003-05-14
Clearance details
- K-number
- K031149
- Device name
- OLYMPIC CFM 6000
- Applicant
- Olympic Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2003-04-10
- Decision date
- 2003-05-14
- Days to decision
- 34 days
- Clearance type
- Special
- Product code
- OMA
- 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.