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FDA 510(k)

EMPTY DIALYSATE CONTAINER BB-69

K-Number: K830689 · 1983-03-29

ApplicantDelmed, Inc.
Decision Date1983-03-29
Product CodeFKX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EMPTY DIALYSATE CONTAINER BB-69 is the device name listed in this FDA 510(k) record. The listed applicant is Delmed, Inc.. It received FDA 510(k) clearance on 1983-03-29 under 510(k) number K830689. The device is classified under product code FKX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMPTY DIALYSATE CONTAINER BB-69?

EMPTY DIALYSATE CONTAINER BB-69 is a medical device that received FDA 510(k) clearance on 1983-03-29. The listed applicant is Delmed, Inc.. The 510(k) number is K830689.

When did EMPTY DIALYSATE CONTAINER BB-69 receive FDA 510(k) clearance?

EMPTY DIALYSATE CONTAINER BB-69 received FDA 510(k) clearance on 1983-03-29, under 510(k) number K830689.

Who is the listed applicant for EMPTY DIALYSATE CONTAINER BB-69?

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

What is the FDA product code for EMPTY DIALYSATE CONTAINER BB-69?

The FDA product code for EMPTY DIALYSATE CONTAINER BB-69 is FKX.

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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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