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FDA 510(k)

EXTRACORPOREAL SINGLE NEEDLE MODULE

K-Number: K822340 · 1982-11-03

ApplicantExtracorporeal Medical Specialities, Inc.
Decision Date1982-11-03
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EXTRACORPOREAL SINGLE NEEDLE MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Extracorporeal Medical Specialities, Inc.. It received FDA 510(k) clearance on 1982-11-03 under 510(k) number K822340. 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 EXTRACORPOREAL SINGLE NEEDLE MODULE?

EXTRACORPOREAL SINGLE NEEDLE MODULE is a medical device that received FDA 510(k) clearance on 1982-11-03. The listed applicant is Extracorporeal Medical Specialities, Inc.. The 510(k) number is K822340.

When did EXTRACORPOREAL SINGLE NEEDLE MODULE receive FDA 510(k) clearance?

EXTRACORPOREAL SINGLE NEEDLE MODULE received FDA 510(k) clearance on 1982-11-03, under 510(k) number K822340.

Who is the listed applicant for EXTRACORPOREAL SINGLE NEEDLE MODULE?

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

What is the FDA product code for EXTRACORPOREAL SINGLE NEEDLE MODULE?

The FDA product code for EXTRACORPOREAL SINGLE NEEDLE MODULE is KOC.

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Other records listing Extracorporeal Medical Specialities, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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