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FDA 510(k)

EXP 200 PARALLEL PLATE DIALYZER

K-Number: K811439 · 1981-06-12

ApplicantExtracorporeal Medical Specialities, Inc.
Decision Date1981-06-12
Product CodeFJG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EXP 200 PARALLEL PLATE DIALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Extracorporeal Medical Specialities, Inc.. It received FDA 510(k) clearance on 1981-06-12 under 510(k) number K811439. The device is classified under product code FJG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXP 200 PARALLEL PLATE DIALYZER?

EXP 200 PARALLEL PLATE DIALYZER is a medical device that received FDA 510(k) clearance on 1981-06-12. The listed applicant is Extracorporeal Medical Specialities, Inc.. The 510(k) number is K811439.

When did EXP 200 PARALLEL PLATE DIALYZER receive FDA 510(k) clearance?

EXP 200 PARALLEL PLATE DIALYZER received FDA 510(k) clearance on 1981-06-12, under 510(k) number K811439.

Who is the listed applicant for EXP 200 PARALLEL PLATE DIALYZER?

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

What is the FDA product code for EXP 200 PARALLEL PLATE DIALYZER?

The FDA product code for EXP 200 PARALLEL PLATE DIALYZER is FJG.

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Other records listing Extracorporeal Medical Specialities, 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.

K843955EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATORK840532HEMOPERFUSION SYSTEM TP-400K840262HANCOCK PERICARDIAL PATCHK840057EXP* 500 PARALLEL PLATE DIALYZERK840146EXP* 700 PARALLEL PLATE DIALYZERK832547ULTRAFILTRATION CONTROLLER

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Related Devices (Code: FJG)

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.

K933681GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERSCobe Renal Care, Inc.K933680GAMBRO LUNDIA PRO 200 DIALYZERCobe Renal Care, Inc.K920693DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9National Medical Care, Medical Products Div., Inc.K915504GAMBRO LUNDIA ALPHA HEMODIALYZERSC.G.H. Medical, Inc.K901368HEMOSPAL KITS A1, A2D, AO, & A1DGambro-Hospal, Inc.K902203TENCKHOFF PERITONEAL DIALYSIS KITAkcess Medical Products, 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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