Thermometer, Clinical Color Change

Device Code: 2593

Product Code(s): FQZ

Device Classification Information

• Device Type ID: 2593
• Device Name: Thermometer, Clinical Color Change
• Regulation Description: Clinical Color Change Thermometer.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID); General Hospital Devices Branch (GHDB)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 880.2900 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: FQZ
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 6-70 ASTM E825-98 (Reapproved 2016)
  Standard Specification For Phase Change-Type Disposable Fever Thermometer For Intermittent Determination Of Human Temperature

Total Product Life Cycle

• Device Type ID: 2593
• Device: Thermometer, Clinical Color Change
• Product Code: FQZ
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Clinical Color Change Thermometer.
• CFR Regulation Number: 880.2900 [🔎]

TPLC Last Update: 2019-04-02 20:15:41