Pneumotachometer

Device Code: 128

Product Code(s): JAX

Device Classification Information

• Device Type ID: 128
• Device Name: Pneumotachometer
• Regulation Description: Pneumotachometer.
• 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) Exempt
• CFR Regulation Number: 868.2550 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: JAX
• 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: 128
• Device: Pneumotachometer
• Product Code: JAX
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Pneumotachometer.
• CFR Regulation Number: 868.2550 [🔎]

Recalls
Manufacturer		Recall Class	Date Posted
1	Philips Medical Systems (Cleveland) Inc	II	Sep-22-2014

TPLC Last Update: 2019-04-02 19:29:26