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FDA 510(k)

FRESENIUS HEMODIALYSIS MACHINE A1008 BSM

K-Number: K855001 · 1986-01-21

ApplicantSeratronics, Inc.
Decision Date1986-01-21
Product CodeFLC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FRESENIUS HEMODIALYSIS MACHINE A1008 BSM is the device name listed in this FDA 510(k) record. The listed applicant is Seratronics, Inc.. It received FDA 510(k) clearance on 1986-01-21 under 510(k) number K855001. The device is classified under product code FLC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRESENIUS HEMODIALYSIS MACHINE A1008 BSM?

FRESENIUS HEMODIALYSIS MACHINE A1008 BSM is a medical device that received FDA 510(k) clearance on 1986-01-21. The listed applicant is Seratronics, Inc.. The 510(k) number is K855001.

When did FRESENIUS HEMODIALYSIS MACHINE A1008 BSM receive FDA 510(k) clearance?

FRESENIUS HEMODIALYSIS MACHINE A1008 BSM received FDA 510(k) clearance on 1986-01-21, under 510(k) number K855001.

Who is the listed applicant for FRESENIUS HEMODIALYSIS MACHINE A1008 BSM?

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 HEMODIALYSIS MACHINE A1008 BSM?

The FDA product code for FRESENIUS HEMODIALYSIS MACHINE A1008 BSM is FLC.

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Other records listing Seratronics, 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.

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: FLC)

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.

K910656WILSON-COOK DISPOSABLE BIOPSY FORCEPSWilson-Cook Medical, Inc.K791164NEGATOVE PRESSURE CONVERTORMedicorp, Inc.K760725COIL MACHINE ADAPTERGambro, 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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