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FDA 510(k)

EMPTY DIALYSATE CONTAINER

K-Number: K831689 · 1983-08-11

ApplicantDelmed, Inc.
Decision Date1983-08-11
Product CodeFKK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EMPTY DIALYSATE CONTAINER is the device name listed in this FDA 510(k) record. The listed applicant is Delmed, Inc.. It received FDA 510(k) clearance on 1983-08-11 under 510(k) number K831689. The device is classified under product code FKK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMPTY DIALYSATE CONTAINER?

EMPTY DIALYSATE CONTAINER is a medical device that received FDA 510(k) clearance on 1983-08-11. The listed applicant is Delmed, Inc.. The 510(k) number is K831689.

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

EMPTY DIALYSATE CONTAINER received FDA 510(k) clearance on 1983-08-11, under 510(k) number K831689.

Who is the listed applicant for EMPTY DIALYSATE CONTAINER?

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?

The FDA product code for EMPTY DIALYSATE CONTAINER is FKK.

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Other records listing Delmed, 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.

K895650ENTERAL PUMP SET W/ENTERA-FLO SPIKEK895329600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERAK895142ENTERAL PUMP SET WITH ENTERAL SPIKEK894506ENTERA-FLO ENTERAL FEEDING PUMPK901478DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTIONK901477DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION

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Related Devices (Code: FKK)

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.

K854512TUBING CLAMP CAT#1000-ARao Medical Devices, Inc.K854517NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SETTravenol Laboratories, S.A.K844121CLAMP, TUBING, LINEDyn-A-Med ProductsK822551AMP CAPD UNISPIKE AMINISTRATION SETAmerican Medical Products, Inc.K802009FLOWCLAMP CAT.#1011 & 1012Pollak (Intl.), Ltd.

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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