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FDA 510(k)

AK-10

K-Number: K771227 · 1977-08-02

ApplicantGambro, Inc.
Decision Date1977-08-02
Product CodeFIL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AK-10 is the device name listed in this FDA 510(k) record. The listed applicant is Gambro, Inc.. It received FDA 510(k) clearance on 1977-08-02 under 510(k) number K771227. The device is classified under product code FIL. It was reviewed by the GU advisory panel. Product code FIL falls under the category of Radiology, which covers imaging devices and accessories used in diagnostic radiology. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AK-10?

AK-10 is a medical device that received FDA 510(k) clearance on 1977-08-02. The listed applicant is Gambro, Inc.. The 510(k) number is K771227.

When did AK-10 receive FDA 510(k) clearance?

AK-10 received FDA 510(k) clearance on 1977-08-02, under 510(k) number K771227.

Who is the listed applicant for AK-10?

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 AK-10?

The FDA product code for AK-10 is FIL. This falls under the Radiology category.

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: FIL)

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.

K011741CRIT-LINE MONITOR III TQA (CLM TQA)HemametricsK901038SPS 550-IPS (INTEGRATED PATIENT STATION)Baxter Healthcare CorpK890329FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEMFresenius USA, Inc.K790824REPGREEN ULTRAFILTRATION MONITORCyberex Corp.K781633ULTRAFILTRATION SCALEExtracorporeal Medical Specialities, Inc.K771875ULTRAFILTRATION MONITOR 5M9034Travenol Laboratories, S.A.

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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