OXYTEC, MODEL 900
FDA 510(k) clearance K043615 · decided 2005-02-09
Clearance details
- K-number
- K043615
- Device name
- OXYTEC, MODEL 900
- Applicant
- Oxytec Medical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2004-12-30
- Decision date
- 2005-02-09
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- CAW
- Device class
- 2
- Regulation number
- 868.5440
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mccordsville, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.