S HEALTH

Transmitters And Receivers, Physiological Signal, Radiofrequency

SAMSUNG ELECTRONICS CO., LTD.

The following data is part of a premarket notification filed by Samsung Electronics Co., Ltd. with the FDA for S Health.

Pre-market Notification Details

• Device ID: K132148
• 510k Number: K132148
• Device Name: S HEALTH
• Classification: Transmitters And Receivers, Physiological Signal, Radiofrequency
• Applicant: SAMSUNG ELECTRONICS CO., LTD. 129, SAMSUNG-RO, YEONGTONG-GU Suwon-si, Gyeonggi-do, KR 443-742
• Contact: Priscilla Chung
• Correspondent: Priscilla Chung; SAMSUNG ELECTRONICS CO., LTD. 129, SAMSUNG-RO, YEONGTONG-GU Suwon-si, Gyeonggi-do, KR 443-742
• Product Code: DRG
• Subsequent Product Code: DXN
• Subsequent Product Code: FRI
• Subsequent Product Code: NBW
• CFR Regulation Number: 870.2910 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-07-11
• Decision Date: 2013-12-04
• Summary: summary