PURITAN-BENNETT VENTILATOR SYSTEM WITH ET/TRACHEOSTOMY TUBE COMPENSATION, TC, OPTION, MODEL 840
FDA 510(k) clearance K993071 · decided 1999-11-24
Clearance details
- K-number
- K993071
- Device name
- PURITAN-BENNETT VENTILATOR SYSTEM WITH ET/TRACHEOSTOMY TUBE COMPENSATION, TC, OPTION, MODEL 840
- Applicant
- Puritan Bennett Corp.
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Date received
- 1999-09-14
- Decision date
- 1999-11-24
- Days to decision
- 71 days
- Clearance type
- Special
- 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
| Record | Firm | Date |
|---|---|---|
| Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision AB-AG. T recall (Z-0611-2014) | Covidien | 2014-01-03 |