ESPRIT VENTILATOR
FDA 510(k) clearance K981072 · decided 1998-11-12
Clearance details
- K-number
- K981072
- Device name
- ESPRIT VENTILATOR
- Applicant
- Respironics, Inc.
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Date received
- 1998-03-24
- Decision date
- 1998-11-12
- Days to decision
- 233 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Pittsburgh, PA, US
- Third-party review
- No
- Expedited review
- No
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