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FDA 510(k)

HEALTHTRONIC OMEGA TRAC

K-Number: K881902 · 1988-06-22

ApplicantHealthtronics Surgical Services, Inc.
Decision Date1988-06-22
Product CodeJFB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HEALTHTRONIC OMEGA TRAC is the device name listed in this FDA 510(k) record. The listed applicant is Healthtronics Surgical Services, Inc.. It received FDA 510(k) clearance on 1988-06-22 under 510(k) number K881902. The device is classified under product code JFB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEALTHTRONIC OMEGA TRAC?

HEALTHTRONIC OMEGA TRAC is a medical device that received FDA 510(k) clearance on 1988-06-22. The listed applicant is Healthtronics Surgical Services, Inc.. The 510(k) number is K881902.

When did HEALTHTRONIC OMEGA TRAC receive FDA 510(k) clearance?

HEALTHTRONIC OMEGA TRAC received FDA 510(k) clearance on 1988-06-22, under 510(k) number K881902.

Who is the listed applicant for HEALTHTRONIC OMEGA TRAC?

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

What is the FDA product code for HEALTHTRONIC OMEGA TRAC?

The FDA product code for HEALTHTRONIC OMEGA TRAC is JFB.

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 Healthtronics Surgical Services, 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.

K012785TWINTRODE ELC 134 ELECTRODE

Related Devices (Code: JFB)

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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