FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
ENVOY PATIENT MONITOR
K Number: K030722
·
Decision Feb 26, 2004
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
424
Applicant Total
34
Review Days
356
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
- ENVOY PATIENT MONITOR
- K Number
- K030722
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mennen Medical, Inc.
- Date Received
- March 7, 2003
- Decision Date
- February 26, 2004
- 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 Mennen Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K983864 | ETCO2 VITAL SIGNS MODULE | Oct 8, 1999 | Substantially Equivalent |
| K991775 | MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WS | Jun 24, 1999 | Substantially Equivalent |
| K982697 | MODIFICATION TO ENSEMBLE CENTRAL STATION MONITOR | Aug 12, 1998 | Substantially Equivalent |
| K974510 | ENVOY PATIENT MONITOR | Apr 14, 1998 | Substantially Equivalent |
| K970358 | ENSEMBLE CENTRAL STATION MONITOR | Feb 11, 1998 | Substantially Equivalent |
| K940081 | MERCURY | Apr 12, 1995 | Substantially Equivalent |
| K940415 | HORIZON 9000 WS | Jan 6, 1995 | Substantially Equivalent |
| K920915 | CAPNOMED 100 STAND-ALONE ETCO2 MODULE | Mar 23, 1993 | Substantially Equivalent |
| K914381 | HORIZON 9000/HIS OPTION AMPLIFIER | Jan 28, 1992 | Substantially Equivalent |
| K913339 | HORIZON PACEMAKER DETECTION SOFTWARE | Jan 8, 1992 | Substantially Equivalent |