HIGH FREQUENCY VENTILATOR
FDA premarket approval P880013/S007 · decided 1997-06-24
Approval details
- PMA number
- P880013
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HIGH FREQUENCY VENTILATOR
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Applicant
- Nellcor Puritan Bennett, Inc.
- Date received
- 1996-10-11
- Decision date
- 1997-06-24
- Days to decision
- 256 days
- Decision code
- APPR
- Product code
- LSZ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Carlsbad, CA
- Statement
- APPROVAL FOR A MANUFACTURING SITE AT NELLCOR PURITAN BENNETT, 2200 FARADAY AVE., CARLSBAD, CA.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DURAMAX REUSABLE OXIMETRY SENSOR (K070408) | Nellcor Puritan Bennett, Inc. | 2007-05-25 |
| NELLCOR OXIMAX N-600X PULSE OXIMETER (K060576) | Nellcor Puritan Bennett, Inc. | 2006-08-14 |
| OXIMAX NEOMAX ADHESIVE FOREHEAD REFLECTANCE OXIMETRY SENSOR (K051271) | Nellcor Puritan Bennett, Inc. | 2006-01-10 |
| NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, MAX-I, MAX-P (K052186) | Nellcor Puritan Bennett, Inc. | 2005-11-10 |
| OXIMAX NPB-40 HANDHELD PULSE OXIMETER (K051352) | Nellcor Puritan Bennett, Inc. | 2005-08-11 |
| GOODKNIGHT 425ST (K050072) | Nellcor Puritan Bennett, Inc. | 2005-06-13 |
| OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR (K033973) | Nellcor Puritan Bennett, Inc. | 2004-12-13 |
| SHILEY FLEXTRA TRACHEOSTOMY TUBE (K030787) | Nellcor Puritan Bennett, Inc. | 2003-11-14 |