OtoSet- Ear Cleaning System
K-Number: K201877 · 2020-11-05
ApplicantSafkan, Inc.
Decision Date2020-11-05
Product CodeKYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
OtoSet- Ear Cleaning System is the device name listed in this FDA 510(k) record. The listed applicant is Safkan, Inc.. It received FDA 510(k) clearance on 2020-11-05 under 510(k) number K201877. The device is classified under product code KYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the OtoSet- Ear Cleaning System?
OtoSet- Ear Cleaning System is a medical device that received FDA 510(k) clearance on 2020-11-05. The listed applicant is Safkan, Inc.. The 510(k) number is K201877.
When did OtoSet- Ear Cleaning System receive FDA 510(k) clearance?
OtoSet- Ear Cleaning System received FDA 510(k) clearance on 2020-11-05, under 510(k) number K201877.
Who is the listed applicant for OtoSet- Ear Cleaning System?
The FDA 510(k) record lists Safkan, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OtoSet- Ear Cleaning System?
The FDA product code for OtoSet- Ear Cleaning System is KYZ.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.