DRAGER OXYLOG 2000
FDA 510(k) clearance K984577 · decided 1999-01-22
Clearance details
- K-number
- K984577
- Device name
- DRAGER OXYLOG 2000
- Applicant
- Drager, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-12-23
- Decision date
- 1999-01-22
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Telford, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.