| Device Type ID | 747 |
| Device Name | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Regulation Description | Radiofrequency Physiological Signal Transmitter And Receiver. |
| 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 | 870.2910 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DRG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
|
| Device Type ID | 747 |
| Device | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Product Code | DRG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Radiofrequency Physiological Signal Transmitter And Receiver. |
| CFR Regulation Number | 870.2910 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CELLCO PARTNERSHIP D/B/A VERIZON WIRELESS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ENTRA HEALTH SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HEALTHINTERLINK, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HMICRO, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HONEYWELL HOMMED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HONEYWELL HOMMED, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LG ELECTRONICS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDICOMP | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDICOMP INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MORTARA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MORTARA INSTRUMENT, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SANITAS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VITAL CONNECT INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VITAL CONNECT, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Thermal Decomposition Of Device | 238 |
Failure To Power Up | 156 |
Device Operates Differently Than Expected | 93 |
Adverse Event Without Identified Device Or Use Problem | 88 |
Device Inoperable | 51 |
Power Conditioning Problem | 45 |
Communication Or Transmission Problem | 41 |
Charred | 34 |
Overheating Of Device | 18 |
Temperature Problem | 15 |
Radio Signal Problem | 14 |
Loss Of Power | 14 |
Device Component Or Accessory | 14 |
Power Supply | 14 |
Wireless Communication Problem | 13 |
No Display / Image | 10 |
Break | 8 |
Device Issue | 7 |
Melted | 7 |
Device Operational Issue | 7 |
Failure To Fire | 7 |
Device Stops Intermittently | 7 |
Adapter (Adaptor) | 6 |
Radiofrequency Interference (RFI) | 5 |
Smoking | 5 |
Appropriate Term/Code Not Available | 5 |
Device Displays Incorrect Message | 4 |
Sparking | 4 |
Device Emits Odor | 4 |
Power Cord | 3 |
Burst Container Or Vessel | 3 |
Battery Problem | 3 |
Application Interface Becomes Non-Functional Or Program Exits Abnormally | 3 |
Device Sensing Problem | 3 |
Battery | 2 |
Power Problem | 2 |
Fire | 2 |
Cable | 2 |
Unintended Electrical Shock | 2 |
Electrical /Electronic Property Problem | 2 |
Invalid Sensing | 2 |
Improper Alarm | 2 |
Incorrect Interpretation Of Signal | 2 |
Telemetry Discrepancy | 2 |
Output Problem | 2 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Moisture Damage | 1 |
Device Markings / Labelling Problem | 1 |
Device Alarm System | 1 |
Alarm Not Visible | 1 |
Electrical Shorting | 1 |
Intermittent Continuity | 1 |
Device Difficult To Maintain | 1 |
Incorrect Measurement | 1 |
Application Program Version Or Upgrade Problem | 1 |
Application Security Problem | 1 |
Telemetry Equipment | 1 |
Antenna | 1 |
False Alarm | 1 |
Failure To Capture | 1 |
Failure To Service | 1 |
Inappropriate Shock | 1 |
Failure To Read Input Signal | 1 |
Material Integrity Problem | 1 |
Material Discolored | 1 |
Charging Problem | 1 |
| Total Device Problems | 992 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Boston Scientific Corporation | II | Sep-13-2017 |
| 2 | Philips Visicu | II | Apr-04-2017 |
| 3 | Philips Visicu | II | Apr-22-2016 |