Decision Date1986-03-04
Product CodeBTO
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
TRACHEOSTOMY CARE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Dynarex Corp.. It received FDA 510(k) clearance on 1986-03-04 under 510(k) number K855130. The device is classified under product code BTO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TRACHEOSTOMY CARE KIT?
TRACHEOSTOMY CARE KIT is a medical device that received FDA 510(k) clearance on 1986-03-04. The listed applicant is Dynarex Corp.. The 510(k) number is K855130.
When did TRACHEOSTOMY CARE KIT receive FDA 510(k) clearance?
TRACHEOSTOMY CARE KIT received FDA 510(k) clearance on 1986-03-04, under 510(k) number K855130.
Who is the listed applicant for TRACHEOSTOMY CARE KIT?
The FDA 510(k) record lists Dynarex Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TRACHEOSTOMY CARE KIT?
The FDA product code for TRACHEOSTOMY CARE KIT is BTO.
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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.