Product Classification

• Device: digital physical/chemical sterilization process sensor
• Definition: A digital physical/chemical sterilization process sensor is a device intended to monitor one or more parameter(s) of the sterilization process. The adequacy of the sterilization conditions as measured by the parameter(s) is/are indicated by a digital readout of the result.
• Physical State: Device monitors one or more parameters of the sterilization process.
• Technical Method: Sterilization process monitoring using a digital, physical/chemical sensor.
• Target Area: Sterilizer chambers
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: SBE
• Premarket Review: Plastic and Reconstructive Surgery Devices (DHT4B); Plastic and Reconstructive Surgery Devices (DHT4B)
• Submission Type: 510(k)
• Regulation Number: 880.2801
• Device Class: 2
• 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