FDA 510(k)

KEYMED FIBERSCOPE AUTO DISINFECTOR

K-Number: K861821 · 1987-02-12

Decision Date1987-02-12

Product CodeNVE

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

KEYMED FIBERSCOPE AUTO DISINFECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Keymed, Inc.. It received FDA 510(k) clearance on 1987-02-12 under 510(k) number K861821. The device is classified under product code NVE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KEYMED FIBERSCOPE AUTO DISINFECTOR?

KEYMED FIBERSCOPE AUTO DISINFECTOR is a medical device that received FDA 510(k) clearance on 1987-02-12. The listed applicant is Keymed, Inc.. The 510(k) number is K861821.

When did KEYMED FIBERSCOPE AUTO DISINFECTOR receive FDA 510(k) clearance?

KEYMED FIBERSCOPE AUTO DISINFECTOR received FDA 510(k) clearance on 1987-02-12, under 510(k) number K861821.

Who is the listed applicant for KEYMED FIBERSCOPE AUTO DISINFECTOR?

The FDA 510(k) record lists Keymed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KEYMED FIBERSCOPE AUTO DISINFECTOR?

The FDA product code for KEYMED FIBERSCOPE AUTO DISINFECTOR is NVE.

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Other records listing Keymed, Inc. as applicant

K100803OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1 K921179OLYMPUS-KEYMED DISINFECTANT FUME EXTRACTOR DFE-20 K881004OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR K864801THE KEYMED HI-LIGHT 250 LIGHT SOURCE K862000KEYMED FLEXIBLE ESOPHAGEAL DILATORS K860528THE KEYMED FIBERSCOPE STERILIZATION CASE

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.