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
• Predetermined Change Control Plan Authorized: No
• Recalls: CDRH Recalls
• Supplements: S012 S001 S002 S003 S005 S006 S009 S010 S011 S016 S014 ; S015 S032 S041 S034 S033 S039 S038 S051 S052 S053 S054 S035 ; S036 S037 S040 S018 S021 S025 S029 S023 S030 S017 S026 S027 ; S028 S043 S042 S046 S058 S044 S045 S047 S049 S050 S031 S055