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FDA 510(k)

AMD HOME HEALTH MONITOR SYSTEM AND AMD MONITORING STATION

K-Number: K964697 · 1997-02-11

ApplicantAdvance Medical Device, Inc.
Decision Date1997-02-11
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AMD HOME HEALTH MONITOR SYSTEM AND AMD MONITORING STATION is the device name listed in this FDA 510(k) record. The listed applicant is Advance Medical Device, Inc.. It received FDA 510(k) clearance on 1997-02-11 under 510(k) number K964697. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMD HOME HEALTH MONITOR SYSTEM AND AMD MONITORING STATION?

AMD HOME HEALTH MONITOR SYSTEM AND AMD MONITORING STATION is a medical device that received FDA 510(k) clearance on 1997-02-11. The listed applicant is Advance Medical Device, Inc.. The 510(k) number is K964697.

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

AMD HOME HEALTH MONITOR SYSTEM AND AMD MONITORING STATION received FDA 510(k) clearance on 1997-02-11, under 510(k) number K964697.

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

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

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

The FDA product code for AMD HOME HEALTH MONITOR SYSTEM AND AMD MONITORING STATION is DXN.

Related Clinical Trials

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Other records listing Advance Medical Device, 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.

K943200FLOSCOPE SUPER VASCULAR LABK910441FLOSCOPE MICRODOPK905157FLOSCOPE VASCULAR LAB.K903744PHYSICIAN'S CHOICE

Related Devices (Code: DXN)

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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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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