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FDA 510(k)

ENGSTROM EDITH MODELS 500,1000,1500 & 1500F

K-Number: K864095 · 1987-02-20

ApplicantGambro, Inc.
Decision Date1987-02-20
Product CodeBYD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ENGSTROM EDITH MODELS 500,1000,1500 & 1500F is the device name listed in this FDA 510(k) record. The listed applicant is Gambro, Inc.. It received FDA 510(k) clearance on 1987-02-20 under 510(k) number K864095. The device is classified under product code BYD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENGSTROM EDITH MODELS 500,1000,1500 & 1500F?

ENGSTROM EDITH MODELS 500,1000,1500 & 1500F is a medical device that received FDA 510(k) clearance on 1987-02-20. The listed applicant is Gambro, Inc.. The 510(k) number is K864095.

When did ENGSTROM EDITH MODELS 500,1000,1500 & 1500F receive FDA 510(k) clearance?

ENGSTROM EDITH MODELS 500,1000,1500 & 1500F received FDA 510(k) clearance on 1987-02-20, under 510(k) number K864095.

Who is the listed applicant for ENGSTROM EDITH MODELS 500,1000,1500 & 1500F?

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 ENGSTROM EDITH MODELS 500,1000,1500 & 1500F?

The FDA product code for ENGSTROM EDITH MODELS 500,1000,1500 & 1500F is BYD.

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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: BYD)

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.

K955008HEAT & MOISTURE EXCHANGERIntertech Resources, Inc.K954194DISPOSABLE HME/FILTEREngstrom MedicalK953580HEAT MOISTURE EXCHANGERIntertech Resources, Inc.K953507TYPE 1 & 2 (HUMIDAIR I & II)Icor ABK953544HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHTGibeck, Inc.K953620WARM N WET HMEF W/LUER ADAPTERHospitak, 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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