Scale, Stand-on, Patient

Device Code: 2598

Product Code(s): FRI

Device Classification Information

• Device Type ID: 2598
• Device Name: Scale, Stand-on, Patient
• Regulation Description: Stand-on Patient Scale.
• 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: 880.2700 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: FRI
• GMP Exempt: Yes
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 13-53 IEEE ISO 11073-10415 First Edition 2010-05-01
  Health Informatics - Point-of-care Medical Device Communication - Part 10415: Device Specialization - Weighing Scale

Total Product Life Cycle

• Device Type ID: 2598
• Device: Scale, Stand-on, Patient
• Product Code: FRI
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Stand-on Patient Scale.
• CFR Regulation Number: 880.2700 [🔎]

Device Problems
Inappropriate Shock	1
Device Displays Incorrect Message	1
Total Device Problems	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Cardinal Scale Mfg Co	II	Jun-01-2017

TPLC Last Update: 2019-04-02 20:15:45