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FDA 510(k)

GAMBRO ADSORBA 150C

K-Number: K873643 · 1987-12-29

ApplicantGambro, Inc.
Decision Date1987-12-29
Product CodeFLD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GAMBRO ADSORBA 150C is the device name listed in this FDA 510(k) record. The listed applicant is Gambro, Inc.. It received FDA 510(k) clearance on 1987-12-29 under 510(k) number K873643. 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 GAMBRO ADSORBA 150C?

GAMBRO ADSORBA 150C is a medical device that received FDA 510(k) clearance on 1987-12-29. The listed applicant is Gambro, Inc.. The 510(k) number is K873643.

When did GAMBRO ADSORBA 150C receive FDA 510(k) clearance?

GAMBRO ADSORBA 150C received FDA 510(k) clearance on 1987-12-29, under 510(k) number K873643.

Who is the listed applicant for GAMBRO ADSORBA 150C?

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

What is the FDA product code for GAMBRO ADSORBA 150C?

The FDA product code for GAMBRO ADSORBA 150C is FLD.

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Other records listing Gambro, Inc. 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.

K083158EXALIS, SOFTWARE VERSION 1.15K070643PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35K032431PRISMA M60/M100 SETSK896758GAMBRO BICARBONATE MONITOR BCM 10-3K896757GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWSK902481GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER

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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.K971015AHCS HEMOPERFUSION SYSTEMAmerican Health Care Systems, Inc.K953751BIOLOGIC-DT SYSTEMHemocleanse, 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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