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FDA 510(k)

OMNI STIM II

K-Number: K813604 · 1982-03-08

ApplicantOmni Intl., Inc.
Decision Date1982-03-08
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

OMNI STIM II is the device name listed in this FDA 510(k) record. The listed applicant is Omni Intl., Inc.. It received FDA 510(k) clearance on 1982-03-08 under 510(k) number K813604. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNI STIM II?

OMNI STIM II is a medical device that received FDA 510(k) clearance on 1982-03-08. The listed applicant is Omni Intl., Inc.. The 510(k) number is K813604.

When did OMNI STIM II receive FDA 510(k) clearance?

OMNI STIM II received FDA 510(k) clearance on 1982-03-08, under 510(k) number K813604.

Who is the listed applicant for OMNI STIM II?

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

What is the FDA product code for OMNI STIM II?

The FDA product code for OMNI STIM II is IPF.

Other records listing Omni Intl., Inc. as applicant

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Related Devices (Code: IPF)

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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