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FDA 510(k)

BEDSIDE CONSOLE HA-57P/BLOOD & HEPARIN PUMP BIP-BH

K-Number: K854479 · 1985-12-16

ApplicantNipro Company, Ltd.
Decision Date1985-12-16
Product CodeFKP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BEDSIDE CONSOLE HA-57P/BLOOD & HEPARIN PUMP BIP-BH is the device name listed in this FDA 510(k) record. The listed applicant is Nipro Company, Ltd.. It received FDA 510(k) clearance on 1985-12-16 under 510(k) number K854479. The device is classified under product code FKP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BEDSIDE CONSOLE HA-57P/BLOOD & HEPARIN PUMP BIP-BH?

BEDSIDE CONSOLE HA-57P/BLOOD & HEPARIN PUMP BIP-BH is a medical device that received FDA 510(k) clearance on 1985-12-16. The listed applicant is Nipro Company, Ltd.. The 510(k) number is K854479.

When did BEDSIDE CONSOLE HA-57P/BLOOD & HEPARIN PUMP BIP-BH receive FDA 510(k) clearance?

BEDSIDE CONSOLE HA-57P/BLOOD & HEPARIN PUMP BIP-BH received FDA 510(k) clearance on 1985-12-16, under 510(k) number K854479.

Who is the listed applicant for BEDSIDE CONSOLE HA-57P/BLOOD & HEPARIN PUMP BIP-BH?

The FDA 510(k) record lists Nipro Company, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BEDSIDE CONSOLE HA-57P/BLOOD & HEPARIN PUMP BIP-BH?

The FDA product code for BEDSIDE CONSOLE HA-57P/BLOOD & HEPARIN PUMP BIP-BH is FKP.

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Related Devices (Code: FKP)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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