Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 And SA-09

System, Measurement, Blood-pressure, Non-invasive

Edan Instruments, Inc.

The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Ambulatory Blood Pressure Monitor, Models: Sa-10, Sa-05, Sa-06, Sa-08 And Sa-09.

Pre-market Notification Details

• Device ID: K210139
• 510k Number: K210139
• Device Name: Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 And SA-09
• Classification: System, Measurement, Blood-pressure, Non-invasive
• Applicant: Edan Instruments, Inc. #15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District Shenzhen, CN 518122
• Contact: Ying Dai
• Correspondent: Ying Dai; Edan Instruments, Inc. #15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District Shenzhen, CN 518122
• Product Code: DXN
• CFR Regulation Number: 870.1130 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-01-19
• Decision Date: 2021-10-01

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
06944413812673	K210139	000
06944413812666	K210139	000
06944413812659	K210139	000
06944413812697	K210139	000
06944413812680	K210139	000