MODEL 7200AE VENTILATOR
FDA 510(k) clearance K922705 · decided 1994-09-22
Clearance details
- K-number
- K922705
- Device name
- MODEL 7200AE VENTILATOR
- Applicant
- Puritan Bennett Corp.
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Date received
- 1992-06-05
- Decision date
- 1994-09-22
- Days to decision
- 839 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.