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FDA 510(k)

GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS

K-Number: K915154 · 1992-05-27

ApplicantC.G.H. Medical, Inc.
Decision Date1992-05-27
Product CodeCAN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS is the device name listed in this FDA 510(k) record. The listed applicant is C.G.H. Medical, Inc.. It received FDA 510(k) clearance on 1992-05-27 under 510(k) number K915154. The device is classified under product code CAN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS?

GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS is a medical device that received FDA 510(k) clearance on 1992-05-27. The listed applicant is C.G.H. Medical, Inc.. The 510(k) number is K915154.

When did GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS receive FDA 510(k) clearance?

GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS received FDA 510(k) clearance on 1992-05-27, under 510(k) number K915154.

Who is the listed applicant for GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS?

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

What is the FDA product code for GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS?

The FDA product code for GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS is CAN.

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Other records listing C.G.H. Medical, 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.

K941708COBE CENTRYSYSTEM CS500 DIALYZERK933818GAMBRO POLYFLUX II HEMODIALYZERIALYZER HEMODIAFILTERK925522CENTRYSYSTEM 3 WITH CHARTS/BP OPTIONK920757FILTRAL HEMODIALYZERSK931720LUNDIA ALPHA 700 HEMODIALYZERK924437HEMOSPAL KIT B22 / MULTIFLOW 60 KIT

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Related Devices (Code: CAN)

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.

K162811MR Conditional CGA 870Essex Industries, Inc.K080243PORTABLE OXYGEN UNIT SCA900San Cheong Co. , Ltd.K060265REMCORE REMOTE CONTROLLED OXYGEN REGULATORRemcore, Inc.K061785CYL-FIL OXYGEN SYSTEMResponsive Respiratory, Inc.K950777OXYGEN REGULATORMada Medical Products, Inc.K942751VANGUARD SERIES GAS REGULATORSBuckman Co., 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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