| Device Type ID | 726 |
| Device Name | Electrocardiograph |
| Regulation Description | Electrocardiograph. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Diagnostics Devices Branch (CDDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.2340 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DPS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 726 |
| Device | Electrocardiograph |
| Product Code | DPS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Electrocardiograph. |
| CFR Regulation Number | 870.2340 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ACME PORTABLE MACHINES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ALIVECOR, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BSP-BIIOLOGICAL SIGNAL PROCESSING, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CARDIOCOMM SOLUTIONS, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CARDIOLOGS TECHNOLOGIES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CONTEC MEDICAL SYSTEM CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CONTEC MEDICAL SYSTEMS CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CONTEC MEDICAL SYSTEMS CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EDAN INSTRUMENTS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 7 | |
FUKUDA DENSHI CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FUKUDA DENSHI USA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GE HEALTHCARE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GENERAL ELECTRIC CO. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GUANGDONG BIOLIGHT MEDITECH CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MITAC INTERNATIONAL CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MORTARA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MORTARA INSTRUMENT, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MORTARA INSTRUMENT, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SCHILLER | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SCHILLER AG | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
SPAULDING CLINICAL RESEARCH, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VALES & HILLS BIOMEDICAL TECH. LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VECTRACOR, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WELCH ALLYN | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WELCH ALLYN, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WIPRO GE HEALTHCARE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZOLL MANUFACTURING CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZYWIE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Unable To Obtain Readings | 8 |
Data Problem | 3 |
Device Operates Differently Than Expected | 3 |
Programming Issue | 1 |
Failure To Read Input Signal | 1 |
Device Sensing Problem | 1 |
Use Of Device Problem | 1 |
Appropriate Term/Code Not Available | 1 |
Output Problem | 1 |
Incorrect Interpretation Of Signal | 1 |
Patient Data Problem | 1 |
| Total Device Problems | 22 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Mortara Instrument, Inc | II | Jun-12-2015 |
| 2 | Philips North America, LLC | II | Feb-21-2019 |