MIE FALCON, DATEX ENGSTROM FLEXIMA II
FDA 510(k) clearance K971030 · decided 1997-11-12
Clearance details
- K-number
- K971030
- Device name
- MIE FALCON, DATEX ENGSTROM FLEXIMA II
- Applicant
- Medical and Industrial Equipment
- Decision
- Substantially Equivalent
- Date received
- 1997-03-20
- Decision date
- 1997-11-12
- Days to decision
- 237 days
- Clearance type
- Traditional
- Product code
- BSZ
- Device class
- 2
- Regulation number
- 868.5160
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Ex2 7na Exeter, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.