MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE

Electrode, Circular (spiral), Scalp And Applicator

GRAPHIC CONTROLS CORP.

The following data is part of a premarket notification filed by Graphic Controls Corp. with the FDA for Medi-trace(r) Fetal Monitoring Spiral Electrode.

Pre-market Notification Details

• Device ID: K904745
• 510k Number: K904745
• Device Name: MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE
• Classification: Electrode, Circular (spiral), Scalp And Applicator
• Applicant: GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. P.O. BOX 1274 Buffalo, NY 14240
• Contact: Van Dine
• Correspondent: Van Dine; GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. P.O. BOX 1274 Buffalo, NY 14240
• Product Code: HGP
• CFR Regulation Number: 884.2675 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-10-18
• Decision Date: 1991-01-29

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10884527002825	K904745	000
20884527002815	K904745	000