Monitor, Airway Pressure (includes Gauge And/or Alarm)

Device Code: 90

Product Code(s): CAP

Device Classification Information

• Device Type ID: 90
• Device Name: Monitor, Airway Pressure (includes Gauge And/or Alarm)
• Regulation Description: Airway Pressure Monitor.
• Regulation Medical Specialty: Anesthesiology
• Review Panel: Anesthesiology
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID); Respiratory Devices Branch (RPDB)
• Submission Type: 510(k)
• CFR Regulation Number: 868.2600 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: CAP
• 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

Total Product Life Cycle

• Device Type ID: 90
• Device: Monitor, Airway Pressure (includes Gauge And/or Alarm)
• Product Code: CAP
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Airway Pressure Monitor.
• CFR Regulation Number: 868.2600 [🔎]

Premarket Reviews
Manufacturer	Decision
BESMED HEALTH BUSINESS CORP.
	SUBSTANTIALLY EQUIVALENT	1
VORTRAN MEDICAL TECHNOLOGY 1, INC.
	SUBSTANTIALLY EQUIVALENT	1
WESTMED HOLDING CO.
	SUBSTANTIALLY EQUIVALENT	1
WESTMED, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Output Problem	3
Total Device Problems	3

TPLC Last Update: 2019-04-02 19:28:45