TELESENSE

Detector And Alarm, Arrhythmia

SCOTTCARE CORPORATION

The following data is part of a premarket notification filed by Scottcare Corporation with the FDA for Telesense.

Pre-market Notification Details

• Device ID: K142180
• 510k Number: K142180
• Device Name: TELESENSE
• Classification: Detector And Alarm, Arrhythmia
• Applicant: SCOTTCARE CORPORATION 4791 WEST 150TH ST. Cleveland, OH 44135
• Contact: Snehraj Merchant
• Correspondent: Snehraj Merchant; SCOTTCARE CORPORATION 4791 WEST 150TH ST. Cleveland, OH 44135
• Product Code: DSI
• CFR Regulation Number: 870.1025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-08-08
• Decision Date: 2014-12-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00856298006213	K142180	000
00856298006152	K142180	000
00856298006145	K142180	000
00856298006138	K142180	000
00856298006039	K142180	000
00856298006022	K142180	000