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FDA 510(k)

SARTORIUS AQUASART SM 40035 - DIALYSATE SYS

K-Number: K850435 · 1985-06-04

ApplicantSartorius Filters, Inc.
Decision Date1985-06-04
Product CodeFKR
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SARTORIUS AQUASART SM 40035 - DIALYSATE SYS is the device name listed in this FDA 510(k) record. The listed applicant is Sartorius Filters, Inc.. It received FDA 510(k) clearance on 1985-06-04 under 510(k) number K850435. The device is classified under product code FKR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SARTORIUS AQUASART SM 40035 - DIALYSATE SYS?

SARTORIUS AQUASART SM 40035 - DIALYSATE SYS is a medical device that received FDA 510(k) clearance on 1985-06-04. The listed applicant is Sartorius Filters, Inc.. The 510(k) number is K850435.

When did SARTORIUS AQUASART SM 40035 - DIALYSATE SYS receive FDA 510(k) clearance?

SARTORIUS AQUASART SM 40035 - DIALYSATE SYS received FDA 510(k) clearance on 1985-06-04, under 510(k) number K850435.

Who is the listed applicant for SARTORIUS AQUASART SM 40035 - DIALYSATE SYS?

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

What is the FDA product code for SARTORIUS AQUASART SM 40035 - DIALYSATE SYS?

The FDA product code for SARTORIUS AQUASART SM 40035 - DIALYSATE SYS is FKR.

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Other records listing Sartorius Filters, 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.

K851818SARTORIUS MINI SART FH 16592K851816SARTORIUS MINISART FH 16534K851817SARTORIUS MINI-SART FH 16555K844504SARTORIUS MINISART SM 16596HYK830487HEMO-PROCESSING SYSTEMK823132SARTOPHOR SYSTEM FOR ELECTROPHORESIS

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Related Devices (Code: FKR)

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.

K111174NXSTAGE PUREFLOW SLNxstage Medical, Inc.K080919NXSTAGE PUREFLOW SLNxstage Medical, Inc.K060296NXSTAGE DIALYSATE PREPARATION MODULENxstage Medical, Inc.K043436NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269Nxstage Medical, Inc.K850756AUTO-D AUTOMATIC DISINFECTION ACCESS/ATTACHMENTSTravenol Laboratories, S.A.K810605CHEMATIC BICARBONATE DIALYSATE SYSTEMTrimedyne, 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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