FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROCARE MONITOR B40
K Number: K120598
·
Decision Jul 19, 2012
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
424
Applicant Total
12
Review Days
142
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PROCARE MONITOR B40
- K Number
- K120598
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ge Medical Systems China Co., Ltd.
- Date Received
- February 28, 2012
- Decision Date
- July 19, 2012
- Product Code
- MHX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MHX), ordered by most recent decision date.
Radius VSM and Accessories
FDA 510(k)
FDA Class 2
·Cardiovascular
M12 Telemetry System
FDA 510(k)
FDA Class 2
·Cardiovascular
ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)
FDA 510(k)
FDA Class 2
·Cardiovascular
Vista CMS
FDA 510(k)
FDA Class 2
·Cardiovascular
uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors
FDA 510(k)
FDA Class 2
·Cardiovascular
Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427)
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Ge Medical Systems China Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K151063 | Monitor B40 | Dec 15, 2015 | Substantially Equivalent |
| K142288 | MAC 800 Resting ECG Analysis System | Dec 3, 2014 | Substantially Equivalent |
| K133576 | MONITOR B40 | Feb 21, 2014 | Substantially Equivalent |
| K130584 | MONITOR B40 | Jun 26, 2013 | Substantially Equivalent |
| K122253 | PROCARE MONITOR B20 | Mar 22, 2013 | Substantially Equivalent |
| K123238 | ACHILLES | Feb 25, 2013 | Substantially Equivalent |
| K103633 | ACHILLES | May 11, 2011 | Substantially Equivalent |
| K102256 | GE LOGIQ I/E & VIVID E COMPACT DIAGNOSTIC ULTRASOUND | Oct 5, 2010 | Substantially Equivalent |
| K102113 | GE VENUE 40 COMPACT DIAGNOSTIC ULTRASOUND | Aug 12, 2010 | Substantially Equivalent |
| K091374 | GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND | May 26, 2009 | Substantially Equivalent |