FDA 510(k)

SINGLE PATIENT SYS. II MODEL DM-450

K-Number: K832053 · 1983-09-29

ApplicantExtracorporeal Medical Specialities, Inc.

Decision Date1983-09-29

Product CodeKOC

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

SINGLE PATIENT SYS. II MODEL DM-450 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 1983-09-29 under 510(k) number K832053. 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 SINGLE PATIENT SYS. II MODEL DM-450?

SINGLE PATIENT SYS. II MODEL DM-450 is a medical device that received FDA 510(k) clearance on 1983-09-29. The listed applicant is Extracorporeal Medical Specialities, Inc.. The 510(k) number is K832053.

When did SINGLE PATIENT SYS. II MODEL DM-450 receive FDA 510(k) clearance?

SINGLE PATIENT SYS. II MODEL DM-450 received FDA 510(k) clearance on 1983-09-29, under 510(k) number K832053.

Who is the listed applicant for SINGLE PATIENT SYS. II MODEL DM-450?

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 SINGLE PATIENT SYS. II MODEL DM-450?

The FDA product code for SINGLE PATIENT SYS. II MODEL DM-450 is KOC.

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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.