FDA 510(k)

DIANEAL SOLUTION EXCHANGE DEVICE #5C4193

K-Number: K822361 · 1982-08-16

Decision Date1982-08-16

Product CodeFKX

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

DIANEAL SOLUTION EXCHANGE DEVICE #5C4193 is the device name listed in this FDA 510(k) record. The listed applicant is Travenol Laboratories, S.A.. It received FDA 510(k) clearance on 1982-08-16 under 510(k) number K822361. 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 DIANEAL SOLUTION EXCHANGE DEVICE #5C4193?

DIANEAL SOLUTION EXCHANGE DEVICE #5C4193 is a medical device that received FDA 510(k) clearance on 1982-08-16. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K822361.

When did DIANEAL SOLUTION EXCHANGE DEVICE #5C4193 receive FDA 510(k) clearance?

DIANEAL SOLUTION EXCHANGE DEVICE #5C4193 received FDA 510(k) clearance on 1982-08-16, under 510(k) number K822361.

Who is the listed applicant for DIANEAL SOLUTION EXCHANGE DEVICE #5C4193?

The FDA 510(k) record lists Travenol Laboratories, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIANEAL SOLUTION EXCHANGE DEVICE #5C4193?

The FDA product code for DIANEAL SOLUTION EXCHANGE DEVICE #5C4193 is FKX.

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Other records listing Travenol Laboratories, S.A. as applicant

K874181BAXTER BEDSIDE SYSTEM K873894CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITE K873873RESUBMITTED MICRON TRANSFUSION FILTER K873984AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)K872364HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 K872652UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM

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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.