FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
IntelliCuff
K Number: K150893
·
Decision Jan 29, 2016
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
37
Applicant Total
26
Review Days
302
Basic Information
- Device Name
- IntelliCuff
- K Number
- K150893
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5750
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- HAMILTON MEDICAL AG
- Date Received
- April 2, 2015
- Decision Date
- January 29, 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 |
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Other Clearances by HAMILTON MEDICAL AG
| K Number | Device Name | ||
|---|---|---|---|
| K163283 | HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 | Sep 20, 2017 | Substantially Equivalent |
| K161450 | HAMILTON-C3 | Apr 27, 2017 | Substantially Equivalent |
| K153046 | HAMILTON-MR1 | Sep 6, 2016 | Substantially Equivalent |
| K152029 | HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010 | May 3, 2016 | Substantially Equivalent |
| K140939 | HAMILTON-T1,HAMILTON-C1 | Sep 2, 2015 | Substantially Equivalent |
| K122438 | HAMILTON-MR1 | Nov 20, 2013 | Substantially Equivalent |
| K131774 | HAMILTON-G5 | Oct 9, 2013 | Substantially Equivalent |
| K123637 | HAMILTON-C3 | Dec 21, 2012 | Substantially Equivalent |
| K121225 | HAMILTON-C2 | Nov 16, 2012 | Substantially Equivalent |
| K120574 | HAMILTON-C1 | May 30, 2012 | Substantially Equivalent |