Amplifier And Signal Conditioner, Transducer Signal

Device Code: 756

Product Code(s): DRQ

Device Classification Information

• Device Type ID: 756
• Device Name: Amplifier And Signal Conditioner, Transducer Signal
• Regulation Description: Transducer Signal Amplifier And Conditioner.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Cardiovascular Devices (DCD); Cardiac Diagnostics Devices Branch (CDDB)
• Submission Type: 510(k)
• CFR Regulation Number: 870.2060 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: DRQ
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

• 3-44 AAMI ANSI BP22:1994 (R2016)
  Blood Pressure Transducers
• 3-115 IEC 60601-2-34 Edition 3.0 2011-05
  Medical Electrical Equipment - Part 2-34: Particular Requirements For The Basic Safety, Including Essential Performance, Of Invasive Blood Pressure Monitoring Equipment

Total Product Life Cycle

• Device Type ID: 756
• Device: Amplifier And Signal Conditioner, Transducer Signal
• Product Code: DRQ
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Transducer Signal Amplifier And Conditioner.
• CFR Regulation Number: 870.2060 [🔎]

Premarket Reviews
Manufacturer	Decision
ACIST MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
ACIST MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORP.
	SUBSTANTIALLY EQUIVALENT	2
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	2

Device Problems
Device Operates Differently Than Expected	3
Amplifier	1
Electrical Power Problem	1
Total Device Problems	5

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	II	Jun-18-2015

TPLC Last Update: 2019-04-02 19:40:39