Product Classification

• Device: monitor, apnea, home use
• Regulation Description: Apnea monitor.
• Definition: Same as the identification for product code FLS, just add home use
• Regulation Medical Specialty: Anesthesiology
• Review Panel: Anesthesiology
• Product Code: NPF
• Premarket Review: Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C); Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
• Submission Type: 510(k)
• Regulation Number: 868.2377
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: Yes

Recognized Consensus Standard

• 1-159 ISO 18778 Second edition 2022-06
  Respiratory equipment - Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors

Third Party Review

Not Third Party Eligible