| Device Type ID | 891 |
| Device Name | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| 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 | MWI |
| 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 | 891 |
| Device | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Product Code | MWI |
| 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 | |
AIRSTRIP TECH | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
AIRSTRIP TECHNOLOGIES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
AIRSTRIP TECHNOLOGIES, LP | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ALERTWATCH LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
AMBIENT CLINICAL ANALYTICS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
AXEO MEDICAL TECHNOLOGIES, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CAPSULE TECHNOLOGIE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CAS MEDICAL SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
COVIDIEN | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
DECISIO HEALTH, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DICTUM HEALTH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EXCEL MEDICAL ELECTRONICS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FYSICON BV | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GE HEALTHCARE | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
GENERAL ELECTRIC CO. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
GUANGDONG BIOLIGHT MEDITECH CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
HILL-ROM, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
INFINIUM MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
INNOKAS YHTYMA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INVIVO | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
IRADIMED CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
LD TECHNOLOGY LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MASIMO CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
MEDICAL INFORMATICS CORP | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MIDMARK CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MIDMARK CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MINDRAY NORTH AMERICA | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PHILIPS MEDICAL SYSTEMS NEDERLANDS B.V. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
REMOTE DIAGNOSTIC TECHNOLOGIES LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
RUDOLF RIESTER GMBH & CO. KG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SKANRAY TECHNOLOGIES PVT LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SKANRAY TECHNOLOGIES PVT LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SOTERA WIRELESS, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SOTERA WIRELESS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
TAIDOC TECHNOLOGY CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TOSENSE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
VIATOM TECHNOLOGY CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VISIOMED TECHNOLOGY CO.,LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WELCH ALLYN, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Incorrect Measurement | 82 |
High Readings | 29 |
Display Or Visual Feedback Problem | 17 |
Inappropriate Or Unexpected Reset | 9 |
Device Operates Differently Than Expected | 7 |
Unable To Obtain Readings | 7 |
Loose Or Intermittent Connection | 4 |
Failure To Run On AC/DC | 4 |
Sensing Intermittently | 4 |
Device Stops Intermittently | 4 |
Low Readings | 3 |
Power Problem | 2 |
Device Displays Incorrect Message | 2 |
No Audible Alarm | 2 |
No Display / Image | 2 |
Image Reversal | 2 |
Overheating Of Device | 2 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Calibration Problem | 1 |
Low Audible Alarm | 1 |
Complete Loss Of Power | 1 |
Device Alarm System | 1 |
Disconnection | 1 |
Failure To Power Up | 1 |
Inadequate Or Insufficient Training | 1 |
Arcing | 1 |
Image Display Error / Artifact | 1 |
Failure To Calibrate | 1 |
Therapeutic Or Diagnostic Output Failure | 1 |
Connection Problem | 1 |
Motherboard | 1 |
Electrical /Electronic Property Problem | 1 |
Device Difficult To Program Or Calibrate | 1 |
Decoupling | 1 |
Battery Problem | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Device Operational Issue | 1 |
| Total Device Problems | 202 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | INNOKAS MEDICAL OY | II | Aug-19-2016 |
| 2 | INNOKAS MEDICAL OY | II | Jan-28-2015 |
| 3 | Innokas Medical Oy | II | Nov-11-2015 |
| 4 | Invivo Corporation | II | Sep-18-2018 |
| 5 | Invivo Corporation | II | Jun-07-2018 |
| 6 | Invivo Corporation | II | May-14-2018 |
| 7 | Invivo Corporation | II | Dec-19-2017 |
| 8 | Invivo Corporation | II | Nov-09-2017 |
| 9 | Invivo Corporation | II | Sep-21-2016 |
| 10 | Invivo Corporation | II | Sep-08-2016 |
| 11 | Invivo Corporation | II | Jan-13-2015 |
| 12 | Invivo Corporation | II | Oct-15-2014 |
| 13 | Invivo Corporation | II | Oct-01-2014 |
| 14 | Invivo Corporation | II | Aug-19-2014 |
| 15 | Invivo Corporation | II | Feb-26-2014 |
| 16 | Invivo Corporation | II | Feb-14-2014 |
| 17 | Mckesson Information Solutions LLC | II | Oct-20-2014 |
| 18 | Mckesson Information Solutions LLC | II | Oct-08-2014 |
| 19 | Medrad Mr Inc | II | Jan-23-2014 |
| 20 | Nellcor Puritan Bennett Inc. (dba Covidien LP) | II | Aug-14-2014 |
| 21 | Philips Electronics North America Corporation | II | Jul-27-2015 |
| 22 | Welch Allyn Protocol, Inc | II | Jan-07-2014 |