FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRACH VOX
K Number: K013728
·
Decision Jul 30, 2002
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
108
Applicant Total
22
Review Days
263
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
- TRACH VOX
- K Number
- K013728
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5800
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Engineered Medical Systems
- Date Received
- November 9, 2001
- Decision Date
- July 30, 2002
- Product Code
- JOH
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| JOH | Tube Tracheostomy And Tube Cuff | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JOH), ordered by most recent decision date.
Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Disposable Inner Cannula XLT
FDA 510(k)
FDA Class 2
·Anesthesiology
Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula
FDA 510(k)
FDA Class 2
·Anesthesiology
TRACOE vario
FDA 510(k)
FDA Class 2
·Anesthesiology
Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff
FDA 510(k)
FDA Class 2
·Anesthesiology
Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set
FDA 510(k)
FDA Class 2
·Anesthesiology
Shiley Neonatal/Pediatric Tracheostomy Tube
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Engineered Medical Systems
| K Number | Device Name | ||
|---|---|---|---|
| K023683 | MULTI-STRAP FULL FACE MASK | Dec 1, 2003 | Substantially Equivalent |
| K013122 | EMS ELECTROSTATIC FLITER AND HME COMBINATION | Apr 19, 2002 | Substantially Equivalent |
| K013089 | EMS HEPA FILTER AND HME COMBINATIONS | Mar 14, 2002 | Substantially Equivalent |
| K013123 | EMS PULMONARY FUNCTION TESTING FILTER | Mar 14, 2002 | Substantially Equivalent |
| K003497 | DISPOSABLE PRESSURE MONITOR | Nov 30, 2000 | Substantially Equivalent |
| K000215 | SWIVEL ELBOW | May 26, 2000 | Substantially Equivalent |
| K000314 | INCENTIVE SPIROMETER | Apr 12, 2000 | Substantially Equivalent |
| K991955 | MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION | Jul 6, 1999 | Substantially Equivalent |
| K991953 | MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION | Jul 1, 1999 | Substantially Equivalent |
| K983919 | EMS MOUTH TO MASK RESUSCITATORS | Apr 7, 1999 | Substantially Equivalent |