VIP PULMONARY FUNCTION SYSTEM
FDA 510(k) clearance K080510 · decided 2008-08-20
Clearance details
- K-number
- K080510
- Device name
- VIP PULMONARY FUNCTION SYSTEM
- Applicant
- Viasys Healthcare GmbH
- Decision
- Substantially Equivalent
- Date received
- 2008-02-25
- Decision date
- 2008-08-20
- Days to decision
- 177 days
- Clearance type
- Special
- Product code
- BTY
- Device class
- 2
- Regulation number
- 868.1890
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Hoechberg, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.