NELLCOR PURITAN BENNETT 700 SERIES VENTILATOR SYSTEM, AND EASYNEB NEBULIZER
FDA 510(k) clearance K990897 · decided 2000-03-15
Clearance details
- K-number
- K990897
- Device name
- NELLCOR PURITAN BENNETT 700 SERIES VENTILATOR SYSTEM, AND EASYNEB NEBULIZER
- Applicant
- Puritan-Bennett Ireland, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1999-03-18
- Decision date
- 2000-03-15
- Days to decision
- 363 days
- Clearance type
- Traditional
- Product code
- CAF
- Device class
- 2
- Regulation number
- 868.5630
- 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 |