FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MaxBlend 2, MaxBlend Lite
K Number: K161718
·
Decision Oct 27, 2016
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
54
Applicant Total
6
Review Days
127
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Basic Information
- Device Name
- MaxBlend 2, MaxBlend Lite
- K Number
- K161718
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5330
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Maxtec, LLC
- Date Received
- June 22, 2016
- Decision Date
- October 27, 2016
- Product Code
- BZR
- 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 |
|---|---|---|---|
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | FDA class 2 | Anesthesiology |
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| K Number | Device Name | ||
|---|---|---|---|
| K231895 | Maxtec MaxBlend2+p | Dec 4, 2023 | Substantially Equivalent |
| K221734 | Maxtec MaxO2 ME+p | Apr 1, 2023 | Substantially Equivalent |
| K182362 | MaxCap Ped and MaxCap Neo | May 23, 2019 | Substantially Equivalent |
| K153659 | MaxO2ME | Jun 10, 2016 | Substantially Equivalent |
| K112402 | ULTRAMAXO2 OXYGEN ANALYER | Dec 14, 2011 | Substantially Equivalent |