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FDA 510(k)

ACCUCHEK II FREEDOM(TM) MONITORING SYSTEM

K-Number: K883817 · 1988-12-09

ApplicantBoehringer Mannheim Corp.
Decision Date1988-12-09
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCUCHEK II FREEDOM(TM) MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1988-12-09 under 510(k) number K883817. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUCHEK II FREEDOM(TM) MONITORING SYSTEM?

ACCUCHEK II FREEDOM(TM) MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 1988-12-09. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K883817.

When did ACCUCHEK II FREEDOM(TM) MONITORING SYSTEM receive FDA 510(k) clearance?

ACCUCHEK II FREEDOM(TM) MONITORING SYSTEM received FDA 510(k) clearance on 1988-12-09, under 510(k) number K883817.

Who is the listed applicant for ACCUCHEK II FREEDOM(TM) MONITORING SYSTEM?

The FDA 510(k) record lists Boehringer Mannheim Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCUCHEK II FREEDOM(TM) MONITORING SYSTEM?

The FDA product code for ACCUCHEK II FREEDOM(TM) MONITORING SYSTEM is CGA.

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Other records listing Boehringer Mannheim Corp. 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.

K984326ELECYS IGE ASSAYK983047ACCU-CHEK HQ SYSTEMK984419ELECSYS IGE CALCHECKK984425MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATORK984372ELECSYS CALCHECK TROPONIN TK984105ELECSYS TROPONIN T STAT TEST

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Related Devices (Code: CGA)

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K252488ABL90 FLEX PLUS SystemRadiometer Medicals ApsK210933YSI 2900C Biochemistry AnalyzerYsi, Inc.K220328EasyStat 300Medica CorporationK223179Cholestech LDX ™ SystemAlere San Diego, Inc.K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K223710i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, 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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