Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: MODEL 203 LIFE PULSE HIGH FREQUENCY VENTILATOR
• Generic Name: VENTILATOR, HIGH FREQUENCY
• Applicant: BUNNELL, INC.; 436 LAWNDALE DR.; SALT LAKE CITY, UT 84115
• PMA Number: P850064
• Date Received: 09/04/1985
• Decision Date: 06/30/1988
• Product Code: LSZ
• Docket Number: 88M-0263
• Notice Date: 08/10/1988
• Advisory Committee: Anesthesiology
• Expedited Review Granted?: No
• Combination Product: No
• Recalls: CDRH Recalls
• Supplements: S001 S002 S003 S005 S006 S009 S010 S011 S012 S014 S015 ; S016 S017 S018 S021 S023 S025 S026 S027 S028 S029 S030 S031 ; S032 S033 S034 S035 S036 S037 S038 S039 S040 S041 S042 S043 ; S044 S045 S046 S047 S049 S050 S051 S053