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FDA 510(k)

ASN MONITOR SINGLE NEEDLE MONITOR

K-Number: K843531 · 1984-11-16

ApplicantOrganon Teknika Corp.
Decision Date1984-11-16
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ASN MONITOR SINGLE NEEDLE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Organon Teknika Corp.. It received FDA 510(k) clearance on 1984-11-16 under 510(k) number K843531. The device is classified under product code KOC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASN MONITOR SINGLE NEEDLE MONITOR?

ASN MONITOR SINGLE NEEDLE MONITOR is a medical device that received FDA 510(k) clearance on 1984-11-16. The listed applicant is Organon Teknika Corp.. The 510(k) number is K843531.

When did ASN MONITOR SINGLE NEEDLE MONITOR receive FDA 510(k) clearance?

ASN MONITOR SINGLE NEEDLE MONITOR received FDA 510(k) clearance on 1984-11-16, under 510(k) number K843531.

Who is the listed applicant for ASN MONITOR SINGLE NEEDLE MONITOR?

The FDA 510(k) record lists Organon Teknika Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASN MONITOR SINGLE NEEDLE MONITOR?

The FDA product code for ASN MONITOR SINGLE NEEDLE MONITOR is KOC.

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Related Devices (Code: KOC)

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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.

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