Appproval for an endotracheal tube adapter for use with the model 203 life pulse high frequency jet ventilator. The endotracheal tube adaptor will be marketed under the new trade name as the "lifeport" endotracheal tube adapter
| Device | LIFE PULSE HIGH FREQUENCY VENTILATOR ENDOTRACHEAL TUBE ADAPTER |
| Classification Name | Ventilator, High Frequency |
| Generic Name | Ventilator, High Frequency |
| Applicant | BUNNELL, INC. |
| Date Received | 1995-04-05 |
| Decision Date | 1995-12-18 |
| PMA | P850064 |
| Supplement | S011 |
| Product Code | LSZ |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| Advisory Committee | Anesthesiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BUNNELL, INC. 436 Lawndale Dr. salt Lake City, UT 84115 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P850064 | | Original Filing |
| S047 |
2022-03-07 |
30-day Notice |
| S046 |
2021-05-27 |
30-day Notice |
| S045 | | |
| S044 |
2021-01-28 |
30-day Notice |
| S043 |
2020-10-29 |
30-day Notice |
| S042 |
2019-11-15 |
30-day Notice |
| S041 |
2019-10-24 |
30-day Notice |
| S040 | | |
| S039 |
2019-02-27 |
135 Review Track For 30-day Notice |
| S038 |
2018-10-25 |
30-day Notice |
| S037 |
2018-09-20 |
30-day Notice |
| S036 |
2018-01-29 |
Real-time Process |
| S035 |
2017-10-02 |
Real-time Process |
| S034 |
2017-06-07 |
30-day Notice |
| S033 |
2016-07-22 |
30-day Notice |
| S032 |
2016-05-24 |
Real-time Process |
| S031 |
2016-02-24 |
Real-time Process |
| S030 |
2015-03-31 |
Normal 180 Day Track |
| S029 |
2015-02-18 |
30-day Notice |
| S028 |
2015-02-04 |
Normal 180 Day Track |
| S027 |
2014-08-25 |
Normal 180 Day Track No User Fee |
| S026 |
2014-01-27 |
30-day Notice |
| S025 |
2013-09-09 |
30-day Notice |
| S024 | | |
| S023 |
2013-06-10 |
Normal 180 Day Track |
| S022 | | |
| S021 |
2012-09-07 |
Normal 180 Day Track |
| S020 | | |
| S019 | | |
| S018 |
2010-02-22 |
Normal 180 Day Track |
| S017 |
2001-04-04 |
Normal 180 Day Track |
| S016 |
1999-09-10 |
Special (immediate Track) |
| S015 |
1998-10-21 |
Normal 180 Day Track |
| S014 |
1998-08-28 |
Special (immediate Track) |
| S013 | | |
| S012 |
1997-04-11 |
Special (immediate Track) |
| S011 |
1995-04-05 |
Normal 180 Day Track |
| S010 |
1994-08-05 |
Normal 180 Day Track |
| S009 |
1992-11-27 |
Normal 180 Day Track |
| S008 | | |
| S007 | | |
| S006 |
1991-08-01 |
Normal 180 Day Track |
| S005 |
1990-10-01 |
Normal 180 Day Track |
| S004 | | |
| S003 |
1989-07-24 |
Normal 180 Day Track |
| S002 |
1989-02-09 |
Normal 180 Day Track |
| S001 |
1988-09-19 |
Normal 180 Day Track |
NIH GUDID Devices