FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIONET BM3PLUS PATIENT MONITOR
K Number: K082008
·
Decision Dec 11, 2008
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
305
Applicant Total
11
Review Days
149
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
- BIONET BM3PLUS PATIENT MONITOR
- K Number
- K082008
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bionet Co., Ltd.
- Date Received
- July 15, 2008
- Decision Date
- December 11, 2008
- Product Code
- MWI
- 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 |
|---|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MWI), ordered by most recent decision date.
Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)
FDA 510(k)
FDA Class 2
·Cardiovascular
c-med0 alpha
FDA 510(k)
FDA Class 2
·Cardiovascular
WAVE Clinical Platform (2.0.000)
FDA 510(k)
FDA Class 2
·Cardiovascular
QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)
FDA 510(k)
FDA Class 2
·Cardiovascular
Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal
FDA 510(k)
FDA Class 2
·Cardiovascular
WARD-CSS (v1.2.x)
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Bionet Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K231160 | Cardio Q50, Cardio Q70 | Dec 15, 2023 | Substantially Equivalent |
| K231150 | Cardio P1 | Nov 9, 2023 | Substantially Equivalent |
| K220535 | Cardio10 | Nov 15, 2022 | Substantially Equivalent |
| K220169 | SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25) | Oct 11, 2022 | Substantially Equivalent |
| K130322 | SPM-300 | Nov 15, 2013 | Substantially Equivalent |
| K113306 | CARDIO 7 | Jul 16, 2012 | Substantially Equivalent |
| K102767 | CARDIO XP | Jun 3, 2011 | Substantially Equivalent |
| K090895 | EKG-PLUS II SOFTWARE | Aug 26, 2009 | Substantially Equivalent |
| K043597 | FC 700 FETAL MONITOR | Dec 16, 2005 | Substantially Equivalent |
| K043598 | FC 1400 FETAL MONITOR | Dec 16, 2005 | Substantially Equivalent |