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FDA 510(k)

ODYSSEY

K-Number: K042861 · 2005-01-12

ApplicantPermedics, Inc.
Decision Date2005-01-12
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ODYSSEY is the device name listed in this FDA 510(k) record. The listed applicant is Permedics, Inc.. It received FDA 510(k) clearance on 2005-01-12 under 510(k) number K042861. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ODYSSEY?

ODYSSEY is a medical device that received FDA 510(k) clearance on 2005-01-12. The listed applicant is Permedics, Inc.. The 510(k) number is K042861.

When did ODYSSEY receive FDA 510(k) clearance?

ODYSSEY received FDA 510(k) clearance on 2005-01-12, under 510(k) number K042861.

Who is the listed applicant for ODYSSEY?

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

What is the FDA product code for ODYSSEY?

The FDA product code for ODYSSEY is MUJ.

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 Permedics, 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.

K993895OPTIRAD

Related Devices (Code: MUJ)

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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