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FDA 510(k)

BIOSPAL 3000S

K-Number: K840811 · 1984-04-02

ApplicantHospal Medical Corp.
Decision Date1984-04-02
Product CodeFKQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BIOSPAL 3000S is the device name listed in this FDA 510(k) record. The listed applicant is Hospal Medical Corp.. It received FDA 510(k) clearance on 1984-04-02 under 510(k) number K840811. The device is classified under product code FKQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOSPAL 3000S?

BIOSPAL 3000S is a medical device that received FDA 510(k) clearance on 1984-04-02. The listed applicant is Hospal Medical Corp.. The 510(k) number is K840811.

When did BIOSPAL 3000S receive FDA 510(k) clearance?

BIOSPAL 3000S received FDA 510(k) clearance on 1984-04-02, under 510(k) number K840811.

Who is the listed applicant for BIOSPAL 3000S?

The FDA 510(k) record lists Hospal Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOSPAL 3000S?

The FDA product code for BIOSPAL 3000S is FKQ.

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Other records listing Hospal Medical Corp. as applicant

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Related Devices (Code: FKQ)

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.

K052764DIACAP ULTRA DIALYSIS FLUID FILTERB. Braun Medizintechnologie GmbHK893612TWO TANK DISSOLUTION MODULENational Medical Care, Medical Products Div., Inc.K874084MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDMNational Medical Care, Medical Products Div., Inc.K873421KAWASUMI A.V. FISTULA SETKawasumi Laboratories Co., Ltd.K870889ACID FUCHSIN SOLUTIONSD.R.G. Scientific IndustriesK861730ACTRIL FOR KIDNEY MACHINE DISINFECTANTRenal Systems, Inc.

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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