BIPAP FOCUS
FDA 510(k) clearance K053168 · decided 2006-01-04
Clearance details
- K-number
- K053168
- Device name
- BIPAP FOCUS
- Applicant
- Respironics (Ireland) Limited
- Decision
- Substantially Equivalent
- Date received
- 2005-11-14
- Decision date
- 2006-01-04
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- MNS
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Galway, IE
- Third-party review
- No
- Expedited review
- No
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