NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEM
FDA 510(k) clearance K984379 · decided 1998-12-10
Clearance details
- K-number
- K984379
- Device name
- NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEM
- Applicant
- Puritan Bennett Corp.
- Decision
- Substantially Equivalent
- Date received
- 1998-12-07
- Decision date
- 1998-12-10
- Days to decision
- 3 days
- Clearance type
- Special
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Galway, IE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Puritan Bennett 840 Series Ventilator PB840 Operators Manual Addendum PN 066009A 09/02 The recall (Z-0821-2014) | Nellcor Puritan Bennett Inc. (dba Covidien LP) | 2014-01-24 |
| Puritan Bennett 700 Series Ventilators (PB740 and PB760) PB700 Series Operators Manual: PN recall (Z-0822-2014) | Nellcor Puritan Bennett Inc. (dba Covidien LP) | 2014-01-24 |
| Internal Battery for Puritan Bennett 700 Series Ventilator. recall (Z-0444-05) | Nellcor Puritan Bennett Inc | 2005-01-28 |
| Model 740 and 760 series Ventilators. recall (Z-0445-05) | Nellcor Puritan Bennett Inc | 2005-01-28 |