MaxBlend 2, MaxBlend Lite— 510(k) K161718
Substantially EquivalentMaxtec, LLC
FDA 510(k) clearance K161718 for MaxBlend 2, MaxBlend Lite, Substantially Equivalent on 2016-10-27. Applicant: Maxtec, LLC. Device class: 2.
Clearance details
- Applicant
- Maxtec, LLC
- Product code
- Code BZR
- Device class
- Class 2
- Regulation
- 21 CFR 868.5330
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake City, UT, US
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