| Device Type ID | 888 |
| Device Name | System, Network And Communication, Physiological Monitors |
| 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 | MSX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 888 |
| Device | System, Network And Communication, Physiological Monitors |
| Product Code | MSX |
| 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 TECHNOLOGIES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ASCOM (SWEDEN) AB | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ATHENA GTX | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CERNER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CERNER CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DRAEGER MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DRAEGER MEDICAL SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EARLYSENSE LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PHILIPS MEDICAL SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SHENZHEN MINDRAY BIO-MEIDCAL ELECTRONICS CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VECTRACOR, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 11 |
No Audible Alarm | 5 |
Device Operational Issue | 3 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Alarm Not Visible | 2 |
Unable To Obtain Readings | 2 |
Computer Software Problem | 1 |
Device Slipped | 1 |
Inappropriate Waveform | 1 |
Device Displays Incorrect Message | 1 |
Smoking | 1 |
Use Of Device Problem | 1 |
Appropriate Term/Code Not Available | 1 |
Device Inoperable | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Failure To Fire | 1 |
Battery Problem | 1 |
| Total Device Problems | 36 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ascom US, INC. | II | May-10-2016 |
| 2 | Mindray DS USA, Inc. Dba Mindray North America | II | Feb-08-2018 |
| 3 | Philips Electronics North America Corporation | II | Dec-21-2017 |
| 4 | Spacelabs Healthcare Inc | II | Jan-25-2018 |
| 5 | Vidco, Inc. | II | Jan-04-2016 |
| 6 | Visicu, Inc. | II | Dec-10-2015 |