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FDA 510(k)

FRESENIUS HEMOFLOW F6 AND F8

K-Number: K870725 · 1987-05-01

ApplicantSeratronics, Inc.
Decision Date1987-05-01
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FRESENIUS HEMOFLOW F6 AND F8 is the device name listed in this FDA 510(k) record. The listed applicant is Seratronics, Inc.. It received FDA 510(k) clearance on 1987-05-01 under 510(k) number K870725. The device is classified under product code FJI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRESENIUS HEMOFLOW F6 AND F8?

FRESENIUS HEMOFLOW F6 AND F8 is a medical device that received FDA 510(k) clearance on 1987-05-01. The listed applicant is Seratronics, Inc.. The 510(k) number is K870725.

When did FRESENIUS HEMOFLOW F6 AND F8 receive FDA 510(k) clearance?

FRESENIUS HEMOFLOW F6 AND F8 received FDA 510(k) clearance on 1987-05-01, under 510(k) number K870725.

Who is the listed applicant for FRESENIUS HEMOFLOW F6 AND F8?

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

What is the FDA product code for FRESENIUS HEMOFLOW F6 AND F8?

The FDA product code for FRESENIUS HEMOFLOW F6 AND F8 is FJI.

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Other records listing Seratronics, Inc. as applicant

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K955299DPS 4 DIALYZER PREPARATION SYSTEMK931336DRS 4 DIALYZER REPROCESSING SYSTEMK944539DRS 4 ND DIALYZER REPROCESSING SYSTEMK923529DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCESK914580DRS-4 DIALYZER REPROCESSING SYSTEMK874573FRESENIUS PURISTERIL 340 (TM)

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Related Devices (Code: FJI)

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.

K190459Hemoflow F3 and F4 DialyzersFresenius Medical Care Renal Therapies Group, LLCK122952NIPRO PUREFLUX-L HEMODIALYZERNipro Medical CorporationK043342POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LRGambro Renal ProductsK010366DISPOSABLE STORAGE CAPMolded Products, Inc.K011148ULTRACONCENTRATOR SYSTEMInterpore Cross Intl.K002761FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERSFresenius Medical Care North America

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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