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FDA 510(k)

ANGIOTEC FMX-2220 SYSTEM

K-Number: K891485 · 1989-05-05

ApplicantAndros Analyzers, Inc.
Decision Date1989-05-05
Product CodeLMB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ANGIOTEC FMX-2220 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Andros Analyzers, Inc.. It received FDA 510(k) clearance on 1989-05-05 under 510(k) number K891485. The device is classified under product code LMB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANGIOTEC FMX-2220 SYSTEM?

ANGIOTEC FMX-2220 SYSTEM is a medical device that received FDA 510(k) clearance on 1989-05-05. The listed applicant is Andros Analyzers, Inc.. The 510(k) number is K891485.

When did ANGIOTEC FMX-2220 SYSTEM receive FDA 510(k) clearance?

ANGIOTEC FMX-2220 SYSTEM received FDA 510(k) clearance on 1989-05-05, under 510(k) number K891485.

Who is the listed applicant for ANGIOTEC FMX-2220 SYSTEM?

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

What is the FDA product code for ANGIOTEC FMX-2220 SYSTEM?

The FDA product code for ANGIOTEC FMX-2220 SYSTEM is LMB.

Related Clinical Trials

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.

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Other records listing Andros Analyzers, 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.

K903806ANGIOTEC IMAGE MANAGEMENT SYSTEMK893476ANGIOTEC SPX SPLIT SCREEN DUAL CHANNEL SCAN CONV.K892869ANGIOTEC ZX DIGITAL IMAGE PROCESSORK852463ANDROS ANALYZERS AIRWAY ADAPTER

Related Devices (Code: LMB)

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.

K992131SAMSUNG RAYPAX LONG TERM ARCHIVESamsung Sds Co., Ltd.K984405ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000Intracom Corp.K983447WISE (II) IMAGE MANAGEMENT SYSTEMSectra-Imtec ABK980243PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS)Parameter Developments, Inc.K973463OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVEO Tech, Inc.K973413ID. STORE (RELEASE 2.0)I.S.G. Technologies, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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