NUPREP

Electrode, Electrocardiograph

WEAVER & CO.

The following data is part of a premarket notification filed by Weaver & Co. with the FDA for Nuprep.

Pre-market Notification Details

• Device ID: K885306
• 510k Number: K885306
• Device Name: NUPREP
• Classification: Electrode, Electrocardiograph
• Applicant: WEAVER & CO. 565-C NUCLA WAY Aurora, CO 80011
• Contact: Douglas T Cleveland
• Correspondent: Douglas T Cleveland; WEAVER & CO. 565-C NUCLA WAY Aurora, CO 80011
• Product Code: DRX
• CFR Regulation Number: 870.2360 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1988-12-27
• Decision Date: 1989-02-23

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30891893002247	K885306	000
10891893002281	K885306	000