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FDA 510(k)

HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309

K-Number: K872364 · 1987-10-13

ApplicantTravenol Laboratories, S.A.
Decision Date1987-10-13
Product CodeFII
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 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 1987-10-13 under 510(k) number K872364. The device is classified under product code FII. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309?

HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 is a medical device that received FDA 510(k) clearance on 1987-10-13. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K872364.

When did HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 receive FDA 510(k) clearance?

HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 received FDA 510(k) clearance on 1987-10-13, under 510(k) number K872364.

Who is the listed applicant for HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309?

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 HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309?

The FDA product code for HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 is FII.

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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)K872652UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEMK870801FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD

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Related Devices (Code: FII)

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.

K030470NXSTAGE SYSTEM ONENxstage Medical, Inc.K881270GAMBRO MULTIPURPOSE SYSTEM MPS-10Gambro, Inc.K862716HEMOFILTRATION SYSTEM 10Gambro, Inc.K822386COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPAHospal Medical Corp.

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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