Product Classification

• Device: powered communication system for emergency use
• Definition: Powered environmental control system to support remote nurse call events, including those originating from ventilators, by trained health care providers from outside an isolation unit to avoid unnecessary exposures during the declared public health emergency.
• Physical State: n/a
• Technical Method: n/a
• Target Area: n/a
• Review Panel: Cardiovascular
• Product Code: QNZ
• Premarket Review: Office of Cardiovascular Devices (OHT2); Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
• Not Classified Reason: EUA - Emergency Use Authorization
• Submission Type: EUA - Emergency Use Authorization
• Device Class: Not Classified
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible