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FDA 510(k)

INOGEN SATELLITE CONSERVER, MODEL SC-100

K-Number: K052563 · 2005-10-24

ApplicantMedical Electronic Devices, Inc.
Decision Date2005-10-24
Product CodeNFB
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INOGEN SATELLITE CONSERVER, MODEL SC-100 is the device name listed in this FDA 510(k) record. The listed applicant is Medical Electronic Devices, Inc.. It received FDA 510(k) clearance on 2005-10-24 under 510(k) number K052563. The device is classified under product code NFB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INOGEN SATELLITE CONSERVER, MODEL SC-100?

INOGEN SATELLITE CONSERVER, MODEL SC-100 is a medical device that received FDA 510(k) clearance on 2005-10-24. The listed applicant is Medical Electronic Devices, Inc.. The 510(k) number is K052563.

When did INOGEN SATELLITE CONSERVER, MODEL SC-100 receive FDA 510(k) clearance?

INOGEN SATELLITE CONSERVER, MODEL SC-100 received FDA 510(k) clearance on 2005-10-24, under 510(k) number K052563.

Who is the listed applicant for INOGEN SATELLITE CONSERVER, MODEL SC-100?

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

What is the FDA product code for INOGEN SATELLITE CONSERVER, MODEL SC-100?

The FDA product code for INOGEN SATELLITE CONSERVER, MODEL SC-100 is NFB.

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Other records listing Medical Electronic 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.

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Related Devices (Code: NFB)

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

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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