FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010
K Number: K152029
·
Decision May 3, 2016
Classifications
1
FEI Numbers
108
Registration Numbers
108
Same Product Code
220
Applicant Total
30
Review Days
286
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Basic Information
- Device Name
- HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010
- K Number
- K152029
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5450
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hamilton Medical AG
- Date Received
- July 22, 2015
- Decision Date
- May 3, 2016
- Product Code
- BTT
- 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 |
|---|---|---|---|
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | FDA class 2 | Anesthesiology |
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FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Hamilton Medical AG
| K Number | Device Name | ||
|---|---|---|---|
| K201306 | HAMILTON-C3 | Feb 5, 2021 | Substantially Equivalent |
| K201658 | Hamilton-C6 | Dec 11, 2020 | Substantially Equivalent |
| K193228 | Hamilton-G5 | May 4, 2020 | Substantially Equivalent |
| K181216 | HAMILTON-T1, HAMILTON-C1 | Aug 2, 2019 | Substantially Equivalent |
| 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 |
| K150893 | IntelliCuff | Jan 29, 2016 | Substantially Equivalent |
| K140939 | HAMILTON-T1,HAMILTON-C1 | Sep 2, 2015 | Substantially Equivalent |
| K122438 | HAMILTON-MR1 | Nov 20, 2013 | Substantially Equivalent |