Synchronizer, Electrocardiograph, Nuclear

Device Code: 5335

Product Code(s): IYY

Device Classification Information

• Device Type ID: 5335
• Device Name: Synchronizer, Electrocardiograph, Nuclear
• Regulation Description: Nuclear Electrocardiograph Synchronizer.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 892.1410 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: IYY
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 5335
• Device: Synchronizer, Electrocardiograph, Nuclear
• Product Code: IYY
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Nuclear Electrocardiograph Synchronizer.
• CFR Regulation Number: 892.1410 [🔎]

TPLC Last Update: 2019-04-02 21:04:31