OHMEDA MODEL 5330 ANESTHETIC MONITOR
FDA 510(k) clearance K931439 · decided 1993-10-19
Clearance details
- K-number
- K931439
- Device name
- OHMEDA MODEL 5330 ANESTHETIC MONITOR
- Applicant
- Ohmeda Medical
- Decision
- Substantially Equivalent
- Date received
- 1993-03-22
- Decision date
- 1993-10-19
- Days to decision
- 211 days
- Clearance type
- Traditional
- Product code
- CBQ
- Device class
- 2
- Regulation number
- 868.1500
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Louisville, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.