PC ECG
Electrocardiograph
EDAN INSTRUMENTS, INC.
The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Pc Ecg.
Pre-market Notification Details
| Device ID | K152427 |
| 510k Number | K152427 |
| Device Name: | PC ECG |
| Classification | Electrocardiograph |
| 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 | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-26 |
| Decision Date | 2016-02-05 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 6944413808300 | K152427 | 000 |
| 06944413803299 | K152427 | 000 |
| 06944413803282 | K152427 | 000 |
| 06944413803275 | K152427 | 000 |
| 06944413803268 | K152427 | 000 |
| 06944413803251 | K152427 | 000 |
| 06944413803244 | K152427 | 000 |
| 06944413802049 | K152427 | 000 |
| 00815871021395 | K152427 | 000 |
| 00815871021388 | K152427 | 000 |
| 06944413803350 | K152427 | 000 |
| 06944413803398 | K152427 | 000 |
| 06944413803473 | K152427 | 000 |
| 06944413803787 | K152427 | 000 |
| 06944413803770 | K152427 | 000 |
| 06944413803602 | K152427 | 000 |
| 06944413803596 | K152427 | 000 |
| 06944413803589 | K152427 | 000 |
| 06944413803572 | K152427 | 000 |
| 06944413803541 | K152427 | 000 |
| 06944413803534 | K152427 | 000 |
| 06944413803480 | K152427 | 000 |
| 00815871021371 | K152427 | 000 |
Trademark Results [PC ECG]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PC ECG 78322450 not registered Dead/Abandoned |
BTS Holdings 2003-11-03 |
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