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FDA 510(k)

VISION BG MONITOR

K-Number: K911596 · 1991-05-15

ApplicantBritish-American Medical, Inc.
Decision Date1991-05-15
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VISION BG MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is British-American Medical, Inc.. It received FDA 510(k) clearance on 1991-05-15 under 510(k) number K911596. 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 VISION BG MONITOR?

VISION BG MONITOR is a medical device that received FDA 510(k) clearance on 1991-05-15. The listed applicant is British-American Medical, Inc.. The 510(k) number is K911596.

When did VISION BG MONITOR receive FDA 510(k) clearance?

VISION BG MONITOR received FDA 510(k) clearance on 1991-05-15, under 510(k) number K911596.

Who is the listed applicant for VISION BG MONITOR?

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

What is the FDA product code for VISION BG MONITOR?

The FDA product code for VISION BG MONITOR is CGA.

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 British-American Medical, 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.

K911624VISION BG TEST STRIP

Related Devices (Code: CGA)

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.

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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