COMPANION 2800 VOLUME VENTILATOR
FDA 510(k) clearance K851366 · decided 1985-10-23
Clearance details
- K-number
- K851366
- Device name
- COMPANION 2800 VOLUME VENTILATOR
- Applicant
- Puritan Bennett Corp.
- Decision
- Substantially Equivalent
- Date received
- 1985-04-05
- Decision date
- 1985-10-23
- Days to decision
- 201 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Overland Park, KS, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.