MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE

Automated External Defibrillators (non-wearable)

GRAPHIC CONTROLS CORP.

The following data is part of a premarket notification filed by Graphic Controls Corp. with the FDA for Medi-trace 1510m Combination Defibrillation, Monitoring And Pacing Electrode.

Pre-market Notification Details

• Device ID: K972970
• 510k Number: K972970
• Device Name: MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE
• Classification: Automated External Defibrillators (non-wearable)
• Applicant: GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. P.O. BOX 1271 Buafflo, NY 14240 -1271
• Contact: Kathleen Selover
• Correspondent: Kathleen Selover; GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. P.O. BOX 1271 Buafflo, NY 14240 -1271
• Product Code: MKJ
• CFR Regulation Number: 870.5310 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-08-11
• Decision Date: 1997-08-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10884527020577	K972970	000