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FDA 510(k)

COMPACT EXCHANGE DEVICE 5C4197

K-Number: K851208 · 1985-04-08

ApplicantTravenol Laboratories, S.A.
Decision Date1985-04-08
Product CodeKDJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COMPACT EXCHANGE DEVICE 5C4197 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 1985-04-08 under 510(k) number K851208. The device is classified under product code KDJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPACT EXCHANGE DEVICE 5C4197?

COMPACT EXCHANGE DEVICE 5C4197 is a medical device that received FDA 510(k) clearance on 1985-04-08. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K851208.

When did COMPACT EXCHANGE DEVICE 5C4197 receive FDA 510(k) clearance?

COMPACT EXCHANGE DEVICE 5C4197 received FDA 510(k) clearance on 1985-04-08, under 510(k) number K851208.

Who is the listed applicant for COMPACT EXCHANGE DEVICE 5C4197?

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 COMPACT EXCHANGE DEVICE 5C4197?

The FDA product code for COMPACT EXCHANGE DEVICE 5C4197 is KDJ.

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Other records listing Travenol Laboratories, S.A. 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.

K874181BAXTER BEDSIDE SYSTEMK873894CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITEK873873RESUBMITTED MICRON TRANSFUSION FILTERK873984AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)K872364HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309K872652UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM

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Related Devices (Code: KDJ)

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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