Calculator, Pulmonary Function Data

Device Code: 65

Product Code(s): BZC

Device Classification Information

• Device Type ID: 65
• Device Name: Calculator, Pulmonary Function Data
• Regulation Description: Pulmonary-function Data Calculator.
• 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: 868.1880 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: BZC
• 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: 65
• Device: Calculator, Pulmonary Function Data
• Product Code: BZC
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Pulmonary-function Data Calculator.
• CFR Regulation Number: 868.1880 [🔎]

Premarket Reviews
Manufacturer	Decision
CAREFUSION
	SUBSTANTIALLY EQUIVALENT	2
CIEL MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
COSMED S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
PULMONE ADVANCED MEDICAL DEVICES, LTD
	SUBSTANTIALLY EQUIVALENT	2

Device Problems
Leak / Splash	1
Total Device Problems	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Innovision A/S	II	Sep-08-2016

TPLC Last Update: 2019-04-02 19:27:42