Computer, Blood-pressure

Device Code: 770

Product Code(s): DSK

Device Classification Information

• Device Type ID: 770
• Device Name: Computer, Blood-pressure
• Regulation Description: Blood Pressure Computer.
• 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: 870.1110 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: DSK
• 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: 770
• Device: Computer, Blood-pressure
• Product Code: DSK
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Blood Pressure Computer.
• CFR Regulation Number: 870.1110 [🔎]

Premarket Reviews
Manufacturer	Decision
ENDOPHYS HOLDINGS, LLC
	SUBSTANTIALLY EQUIVALENT	1
ENDOPHYS, INC.
	SUBSTANTIALLY EQUIVALENT	1
VOLCANO CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Leak / Splash	54
Fluid Leak	54
Monitor	2
Material Separation	2
Device Contamination With Chemical Or Other Material	1
No Device Output	1
Inadequate User Interface	1
Loose Or Intermittent Connection	1
Fracture	1
Device Operational Issue	1
Infusion Or Flow Problem	1
Missing Test Results	1
No Display / Image	1
Total Device Problems	121

TPLC Last Update: 2019-04-02 19:41:00