Strip, Temperature, Forehead, Liquid Crystal

Device Code: 2629

Product Code(s): KPD

Device Classification Information

• Device Type ID: 2629
• Device Name: Strip, Temperature, Forehead, Liquid Crystal
• Regulation Description: Liquid Crystal Forehead Temperature Strip.
• 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: 880.2200 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: KPD
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 6-200 ASTM E1061-01 (Reapproved 2014)
  Standard Specification For Direct-Reading Liquid Crystal Forehead Thermometers

Total Product Life Cycle

• Device Type ID: 2629
• Device: Strip, Temperature, Forehead, Liquid Crystal
• Product Code: KPD
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Liquid Crystal Forehead Temperature Strip.
• CFR Regulation Number: 880.2200 [🔎]

TPLC Last Update: 2019-04-02 20:16:24