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FDA 510(k)

AMD HOME HEALTH MONITORING SYSTEM

K-Number: K960337 · 1996-09-24

ApplicantAdvanced Medical Devices, Inc.
Decision Date1996-09-24
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMD HOME HEALTH MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Medical Devices, Inc.. It received FDA 510(k) clearance on 1996-09-24 under 510(k) number K960337. 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 AMD HOME HEALTH MONITORING SYSTEM?

AMD HOME HEALTH MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 1996-09-24. The listed applicant is Advanced Medical Devices, Inc.. The 510(k) number is K960337.

When did AMD HOME HEALTH MONITORING SYSTEM receive FDA 510(k) clearance?

AMD HOME HEALTH MONITORING SYSTEM received FDA 510(k) clearance on 1996-09-24, under 510(k) number K960337.

Who is the listed applicant for AMD HOME HEALTH MONITORING SYSTEM?

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

What is the FDA product code for AMD HOME HEALTH MONITORING SYSTEM?

The FDA product code for AMD HOME HEALTH MONITORING SYSTEM 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 Advanced Medical Devices, 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.

K982793PIEZO TRONIC

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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