HEART SYNC, MODELS C-100 AND T-100

Automated External Defibrillators (non-wearable)

HEART SYNC LLC

The following data is part of a premarket notification filed by Heart Sync Llc with the FDA for Heart Sync, Models C-100 And T-100.

Pre-market Notification Details

• Device ID: K080421
• 510k Number: K080421
• Device Name: HEART SYNC, MODELS C-100 AND T-100
• Classification: Automated External Defibrillators (non-wearable)
• Applicant: HEART SYNC LLC 5643 PLYMOUTH ROAD Ann Arbor, MI 48105
• Contact: Stephen Shulman
• Correspondent: Mark Job; REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114
• Product Code: MKJ
• CFR Regulation Number: 870.5310 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2008-02-15
• Decision Date: 2008-02-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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