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FDA 510(k)

GAMBRO ENGSTROM Y-FILTER WITH EDITH FLEX (1500F)

K-Number: K914271 · 1992-04-13

ApplicantC.G.H. Medical, Inc.
Decision Date1992-04-13
Product CodeCAN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

GAMBRO ENGSTROM Y-FILTER WITH EDITH FLEX (1500F) 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 1992-04-13 under 510(k) number K914271. 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 WITH EDITH FLEX (1500F)?

GAMBRO ENGSTROM Y-FILTER WITH EDITH FLEX (1500F) is a medical device that received FDA 510(k) clearance on 1992-04-13. The listed applicant is C.G.H. Medical, Inc.. The 510(k) number is K914271.

When did GAMBRO ENGSTROM Y-FILTER WITH EDITH FLEX (1500F) receive FDA 510(k) clearance?

GAMBRO ENGSTROM Y-FILTER WITH EDITH FLEX (1500F) received FDA 510(k) clearance on 1992-04-13, under 510(k) number K914271.

Who is the listed applicant for GAMBRO ENGSTROM Y-FILTER WITH EDITH FLEX (1500F)?

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 WITH EDITH FLEX (1500F)?

The FDA product code for GAMBRO ENGSTROM Y-FILTER WITH EDITH FLEX (1500F) 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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