V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS
FDA 510(k) clearance K102985 · decided 2011-04-05
Clearance details
- K-number
- K102985
- Device name
- V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS
- Applicant
- Respironics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-10-07
- Decision date
- 2011-04-05
- Days to decision
- 180 days
- Clearance type
- Traditional
- Product code
- MNT
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Murrysville, PA, US
- Third-party review
- No
- Expedited review
- No
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