FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRANSONIC TISSUE PERFUSION MONITOR
K Number: K140740
·
Decision Jul 23, 2015
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
136
Applicant Total
16
Review Days
485
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
- TRANSONIC TISSUE PERFUSION MONITOR
- K Number
- K140740
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2100
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Transonic Systems, Inc.
- Date Received
- March 25, 2014
- Decision Date
- July 23, 2015
- Product Code
- DPW
- 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 |
|---|---|---|---|
| DPW | Flowmeter, Blood, Cardiovascular | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DPW), ordered by most recent decision date.
FloPatch FP120
FDA 510(k)
FDA Class 2
·Cardiovascular
VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01)
FDA 510(k)
FDA Class 2
·Cardiovascular
FloPatch FP120
FDA 510(k)
FDA Class 2
·Cardiovascular
Elfor-L
FDA 510(k)
FDA Class 2
·Cardiovascular
VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01)
FDA 510(k)
FDA Class 2
·Cardiovascular
FloPatch FP120
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Transonic Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K134051 | TRANSONIC ELSA SYSTEM | Jan 29, 2015 | Substantially Equivalent |
| K134035 | TRANSONIC HCM 103 SYSTEM | Sep 17, 2014 | Substantially Equivalent |
| K140017 | TRANSONIC HCM 102 SYSTEM | Sep 16, 2014 | Substantially Equivalent |
| K113821 | TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM | Sep 7, 2012 | Substantially Equivalent |
| K112657 | AUREFLO MONITORING SYSTEM | Dec 21, 2011 | Substantially Equivalent |
| K080116 | TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM | Sep 8, 2008 | Substantially Equivalent |
| K033424 | ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002 | Dec 11, 2003 | Substantially Equivalent |
| K022963 | TRANSONIC SYRINGE WARMER, MODEL SYR-1000 | Dec 4, 2002 | Substantially Equivalent |
| K021571 | TRANSONIC FLOW-QC SET MODEL ADT1010 | Aug 12, 2002 | Substantially Equivalent |
| K010253 | ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101 | Mar 19, 2002 | Substantially Equivalent |