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FDA 510(k)

PUMPETTE AS8P-INFUSION PUMP

K-Number: K831534 · 1983-09-12

ApplicantTravenol Laboratories, S.A.
Decision Date1983-09-12
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PUMPETTE AS8P-INFUSION PUMP 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 1983-09-12 under 510(k) number K831534. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PUMPETTE AS8P-INFUSION PUMP?

PUMPETTE AS8P-INFUSION PUMP is a medical device that received FDA 510(k) clearance on 1983-09-12. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K831534.

When did PUMPETTE AS8P-INFUSION PUMP receive FDA 510(k) clearance?

PUMPETTE AS8P-INFUSION PUMP received FDA 510(k) clearance on 1983-09-12, under 510(k) number K831534.

Who is the listed applicant for PUMPETTE AS8P-INFUSION PUMP?

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 PUMPETTE AS8P-INFUSION PUMP?

The FDA product code for PUMPETTE AS8P-INFUSION PUMP is FRN.

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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: FRN)

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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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