EMOX
FDA 510(k) clearance K984081 · decided 1999-03-17
Clearance details
- K-number
- K984081
- Device name
- EMOX
- Applicant
- Emox 911 CC
- Decision
- Substantially Equivalent
- Date received
- 1998-11-16
- Decision date
- 1999-03-17
- Days to decision
- 121 days
- Clearance type
- Traditional
- Product code
- CAW
- Device class
- 2
- Regulation number
- 868.5440
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Somerset West, ZA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.