CPU GRAPH
FDA 510(k) clearance K863546 · decided 1986-09-18
Clearance details
- K-number
- K863546
- Device name
- CPU GRAPH
- Applicant
- Ohmeda Medical
- Decision
- Substantially Equivalent
- Date received
- 1986-09-12
- Decision date
- 1986-09-18
- Days to decision
- 6 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Columbia, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.