Apparatus, Nitric Oxide, Backup Delivery

Device Code: 152

Product Code(s): MRO

Device Classification Information

• Device Type ID: 152
• Device Name: Apparatus, Nitric Oxide, Backup Delivery
• Regulation Description: Nitric Oxide Administration Apparatus.
• 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); Anesthesiology Devices Branch (ANDB)
• Submission Type: 510(k)
• CFR Regulation Number: 868.5165 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: MRO
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: Yes
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 152
• Device: Apparatus, Nitric Oxide, Backup Delivery
• Product Code: MRO
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Nitric Oxide Administration Apparatus.
• CFR Regulation Number: 868.5165 [🔎]

TPLC Last Update: 2019-04-02 19:29:48