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FDA 510(k)

AHCS HEMOPERFUSION SYSTEM

K-Number: K971015 · 1997-10-22

ApplicantAmerican Health Care Systems, Inc.
Decision Date1997-10-22
Product CodeFLD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AHCS HEMOPERFUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is American Health Care Systems, Inc.. It received FDA 510(k) clearance on 1997-10-22 under 510(k) number K971015. The device is classified under product code FLD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AHCS HEMOPERFUSION SYSTEM?

AHCS HEMOPERFUSION SYSTEM is a medical device that received FDA 510(k) clearance on 1997-10-22. The listed applicant is American Health Care Systems, Inc.. The 510(k) number is K971015.

When did AHCS HEMOPERFUSION SYSTEM receive FDA 510(k) clearance?

AHCS HEMOPERFUSION SYSTEM received FDA 510(k) clearance on 1997-10-22, under 510(k) number K971015.

Who is the listed applicant for AHCS HEMOPERFUSION SYSTEM?

The FDA 510(k) record lists American Health Care Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AHCS HEMOPERFUSION SYSTEM?

The FDA product code for AHCS HEMOPERFUSION SYSTEM is FLD.

Related Clinical Trials

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Related Devices (Code: FLD)

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.

K113313MOLECULAR ADSORBENT RECIRCULATING(MARS)Gambro Renal Products, Inc.K033262MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS)Gambro Renal ProductsK992196BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK)Hemocleanse, Inc.K984546BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TKHemocleanse, Inc.K953751BIOLOGIC-DT SYSTEMHemocleanse, Inc.K885017HEMOSORBA CH-500, CH-350 AND CH-180Asahi Medical Co., Ltd.

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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