Meter, Peak Flow, Spirometry

Device Code: 69

Product Code(s): BZH

Device Classification Information

• Device Type ID: 69
• Device Name: Meter, Peak Flow, Spirometry
• Regulation Description: Peak-flow Meter For Spirometry.
• 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: 868.1860 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: BZH
• 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

• 13-55 IEEE Std 11073-10421-2010
  Health Informatics - Personal Health Device Communication Part 10421: Device Specialization - Peak Expiratory Flow Monitor (peak Flow)
• 13-92 IEEE ISO 11073-10421 First Edition 2012-11-01
  Health Informatics - Personal Health Device Communication - Part 10421: Device Specialization - Peak Expiratory Flow Monitor (peak Flow)

Total Product Life Cycle

• Device Type ID: 69
• Device: Meter, Peak Flow, Spirometry
• Product Code: BZH
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Peak-flow Meter For Spirometry.
• CFR Regulation Number: 868.1860 [🔎]

Premarket Reviews
Manufacturer	Decision
BEIJING M&B ELECTRONIC INSTRUMENTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BEIJING M&B ELECTRONIC INSTRUMENTS, CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
BESMED HEALTH BUSINESS CORP.
	SUBSTANTIALLY EQUIVALENT	1
SPARO INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Incorrect Measurement	22
Sticking	8
Total Device Problems	30

TPLC Last Update: 2019-04-02 19:27:48