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FDA 510(k)

SONICAID FM820 AND FM830 ENCORE

K-Number: K090285 · 2009-07-15

ApplicantHuntleigh Healthcare , Ltd.
Decision Date2009-07-15
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SONICAID FM820 AND FM830 ENCORE is the device name listed in this FDA 510(k) record. The listed applicant is Huntleigh Healthcare , Ltd.. It received FDA 510(k) clearance on 2009-07-15 under 510(k) number K090285. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONICAID FM820 AND FM830 ENCORE?

SONICAID FM820 AND FM830 ENCORE is a medical device that received FDA 510(k) clearance on 2009-07-15. The listed applicant is Huntleigh Healthcare , Ltd.. The 510(k) number is K090285.

When did SONICAID FM820 AND FM830 ENCORE receive FDA 510(k) clearance?

SONICAID FM820 AND FM830 ENCORE received FDA 510(k) clearance on 2009-07-15, under 510(k) number K090285.

Who is the listed applicant for SONICAID FM820 AND FM830 ENCORE?

The FDA 510(k) record lists Huntleigh Healthcare , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SONICAID FM820 AND FM830 ENCORE?

The FDA product code for SONICAID FM820 AND FM830 ENCORE is HGM.

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Other records listing Huntleigh Healthcare , Ltd. as applicant

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Related Devices (Code: HGM)

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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