PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION
FDA 510(k) clearance K001646 · decided 2000-10-20
Clearance details
- K-number
- K001646
- Device name
- PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION
- Applicant
- Puritan Bennett Corp.
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Date received
- 2000-05-30
- Decision date
- 2000-10-20
- Days to decision
- 143 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
| 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 |