Patient Monitor: RespArray

Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

Edan Instruments, Inc.

The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Patient Monitor: Resparray.

Pre-market Notification Details

• Device ID: K220308
• 510k Number: K220308
• Device Name: Patient Monitor: RespArray
• Classification: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
• Applicant: Edan Instruments, Inc. #15 Jinhui Road, Jinsha Community, Kengzi Sub-District Pingshan District Shenzhen, CN 518122
• Contact: Joan. Wei
• Correspondent: Joan. Wei; Edan Instruments, Inc. #15 Jinhui Road,Jinsha Community, Kengzi Sub-District Pingshan District Shenzhen, CN 518122
• Product Code: MHX
• Subsequent Product Code: CCK
• Subsequent Product Code: DQA
• Subsequent Product Code: DRT
• Subsequent Product Code: DSB
• Subsequent Product Code: DSI
• Subsequent Product Code: DSK
• Subsequent Product Code: DXN
• Subsequent Product Code: FLL
• Subsequent Product Code: MLD
• CFR Regulation Number: 870.1025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-02-02
• Decision Date: 2022-08-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
06944413831988	K220308	000
06944413824829	K220308	000
16944413824833	K220308	000
16944413824840	K220308	000
16944413824857	K220308	000
16944413824864	K220308	000
16944413824871	K220308	000
16944413824888	K220308	000
16944413824895	K220308	000
16944413824901	K220308	000
06944413824812	K220308	000
06944413824805	K220308	000
06944413824713	K220308	000
06944413821316	K220308	000
06944413824737	K220308	000
16944413824741	K220308	000
16944413824758	K220308	000
16944413824765	K220308	000
06944413824775	K220308	000
16944413824789	K220308	000
16944413824796	K220308	000
16944413824918	K220308	000
16944413824925	K220308	000
16944413824932	K220308	000
16944413825052	K220308	000
16944413825069	K220308	000
16944413825076	K220308	000
16944413825083	K220308	000
16944413825090	K220308	000
06944413826168	K220308	000
06944413826175	K220308	000
06944413826182	K220308	000
06944413826199	K220308	000
16944413825045	K220308	000
16944413825038	K220308	000
16944413824949	K220308	000
16944413824956	K220308	000
16944413824963	K220308	000
16944413824970	K220308	000
16944413824987	K220308	000
16944413824994	K220308	000
16944413825007	K220308	000
16944413825014	K220308	000
16944413825021	K220308	000
06944413826205	K220308	000