I-PAD

Automated External Defibrillators (non-wearable)

CU MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Cu Medical Systems, Inc. with the FDA for I-pad.

Pre-market Notification Details

• Device ID: K062970
• 510k Number: K062970
• Device Name: I-PAD
• Classification: Automated External Defibrillators (non-wearable)
• Applicant: CU MEDICAL SYSTEMS, INC. P.O. BOX 560 Stillwater, MN 55082
• Contact: Elaine Duncan
• Correspondent: Elaine Duncan; CU MEDICAL SYSTEMS, INC. P.O. BOX 560 Stillwater, MN 55082
• Product Code: MKJ
• CFR Regulation Number: 870.5310 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-09-29
• Decision Date: 2008-01-22
• Summary: summary