LIFE PULSE HIGH FREQUENCY VENTILATOR ENDOTRACHEAL TUBE ADAPTER
FDA premarket approval P850064/S011 · decided 1995-12-18
Approval details
- PMA number
- P850064
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LIFE PULSE HIGH FREQUENCY VENTILATOR ENDOTRACHEAL TUBE ADAPTER
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Applicant
- Bunnell, Inc.
- Date received
- 1995-04-05
- Decision date
- 1995-12-18
- Days to decision
- 257 days
- Decision code
- APPR
- Product code
- LSZ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Salt Lake City, UT
- Statement
- 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
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