SPIDERVIEW

Electrocardiograph, Ambulatory (without Analysis)

ELA MEDICAL, INC.

The following data is part of a premarket notification filed by Ela Medical, Inc. with the FDA for Spiderview.

Pre-market Notification Details

• Device ID: K032466
• 510k Number: K032466
• Device Name: SPIDERVIEW
• Classification: Electrocardiograph, Ambulatory (without Analysis)
• Applicant: ELA MEDICAL, INC. 2950 XENIUM LN. NORTH, #120 Plymouth, MN 55441
• Contact: Susan Olive
• Correspondent: Susan Olive; ELA MEDICAL, INC. 2950 XENIUM LN. NORTH, #120 Plymouth, MN 55441
• Product Code: MWJ
• CFR Regulation Number: 870.2800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-08-11
• Decision Date: 2003-08-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08031527015149	K032466	000
08031527015064	K032466	000
08031527015071	K032466	000
08031527015088	K032466	000
08031527015095	K032466	000
08031527016023	K032466	000
08031527013398	K032466	000
08031527013411	K032466	000
08031527013428	K032466	000
08031527014876	K032466	000
08031527014883	K032466	000
08031527014890	K032466	000
08031527015132	K032466	000
08031527015057	K032466	000