The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Holter System.
| Device ID | K151787 |
| 510k Number | K151787 |
| Device Name: | Holter System |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | EDAN INSTRUMENTS, INC. 3/F - B, NANSHAN MEDICAL EQUIPMENTS PARK, NANHAI RD 1019# Shenzhen, CN 518067 |
| Contact | Queena Chen |
| Correspondent | Doug Worth EDAN MEDICAL 1200 CROSSMAN AVE. SUITE 200 Sunnyvale, CA 94086 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-01 |
| Decision Date | 2016-01-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944413803909 | K151787 | 000 |
| 06944413800960 | K151787 | 000 |
| 06944413800977 | K151787 | 000 |
| 06944413803619 | K151787 | 000 |
| 06944413803626 | K151787 | 000 |
| 06944413803633 | K151787 | 000 |
| 06944413803640 | K151787 | 000 |
| 06944413803657 | K151787 | 000 |
| 06944413803664 | K151787 | 000 |
| 00815871021425 | K151787 | 000 |