FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
TRACOE Cuff Pressure Monitor
K Number: K152778
·
Decision Dec 21, 2016
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
38
Applicant Total
8
Review Days
453
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Basic Information
- Device Name
- TRACOE Cuff Pressure Monitor
- K Number
- K152778
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5750
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tracoe Medical GmbH
- Date Received
- September 25, 2015
- Decision Date
- December 21, 2016
- Product Code
- BSK
- 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 |
|---|---|---|---|
| BSK | Cuff, Tracheal Tube, Inflatable | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
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Cuffix
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Tracoe Medical GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K203362 | TRACOE vario | Aug 5, 2021 | Substantially Equivalent |
| K172720 | TRACOE silcosoft Tracheostomy Tube | Apr 27, 2018 | Substantially Equivalent |
| K152865 | TRACOE smart Cuff Manager | Sep 27, 2016 | Substantially Equivalent |
| K051587 | TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470 | Oct 25, 2005 | Substantially Equivalent |
| K043160 | TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SO | Feb 18, 2005 | Substantially Equivalent |
| K961449 | TRACHEOSTOMY TUBES TRACOE-FLEX | Sep 13, 1996 | Substantially Equivalent |
| K781729 | TRACHEOTOMY TUBES | Oct 24, 1978 | Substantially Equivalent |