| Device Type ID | 759 |
| Device Name | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Regulation Description | Cardiac Monitor (including Cardiotachometer And Rate Alarm). |
| 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 | 870.2300 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DRT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 759 |
| Device | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Product Code | DRT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cardiac Monitor (including Cardiotachometer And Rate Alarm). |
| CFR Regulation Number | 870.2300 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
IVY BIOMEDICAL SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Unable To Obtain Readings | 206 |
Overheating Of Device | 81 |
Temperature Problem | 70 |
Device Displays Incorrect Message | 60 |
Device Operates Differently Than Expected | 25 |
Device Issue | 18 |
Misassembly By Users | 16 |
Failure Of Device To Self-Test | 16 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 12 |
Device Operational Issue | 12 |
Device Inoperable | 10 |
Output Problem | 10 |
Human Factors Issue | 10 |
Thermal Decomposition Of Device | 8 |
Defibrillation Problem | 6 |
Battery | 6 |
Device Sensing Problem | 5 |
Communication Or Transmission Problem | 5 |
Invalid Sensing | 5 |
Incorrect Measurement | 4 |
Use Of Device Problem | 4 |
Failure To Read Input Signal | 4 |
Device Component Or Accessory | 3 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Failure To Analyze Signal | 3 |
Pacing Problem | 3 |
Device Alarm System | 3 |
Device Handling Problem | 3 |
Loss Of Power | 3 |
Incorrect Interpretation Of Signal | 3 |
Improper Alarm | 2 |
Failure To Discharge | 2 |
Self-Activation Or Keying | 2 |
Appropriate Term/Code Not Available | 2 |
Smoking | 2 |
Pad | 2 |
No Audible Alarm | 2 |
Radiofrequency Interference (RFI) | 2 |
Inappropriate Shock | 2 |
Improper Device Output | 2 |
Battery Problem | 2 |
Electro-Static Discharge | 1 |
Application Interface Becomes Non-Functional Or Program Exits Abnormally | 1 |
Unintended Application Program Shut Down | 1 |
Human-Device Interface Problem | 1 |
Operating System Becomes Nonfunctional | 1 |
No Display / Image | 1 |
Electrode | 1 |
Electrical /Electronic Property Problem | 1 |
Output Above Specifications | 1 |
Defective Alarm | 1 |
Failure To Select Signal | 1 |
Alarm Not Visible | 1 |
Application Program Problem | 1 |
| Total Device Problems | 652 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ansar Group, Inc. Dba Ansar Medical Technologies, Inc | II | Aug-19-2014 |