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FDA 510(k)

SUGITRON MODEL: IEC

K-Number: K980177 · 1998-07-07

ApplicantEllman Intl., Inc.
Decision Date1998-07-07
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUGITRON MODEL: IEC is the device name listed in this FDA 510(k) record. The listed applicant is Ellman Intl., Inc.. It received FDA 510(k) clearance on 1998-07-07 under 510(k) number K980177. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUGITRON MODEL: IEC?

SUGITRON MODEL: IEC is a medical device that received FDA 510(k) clearance on 1998-07-07. The listed applicant is Ellman Intl., Inc.. The 510(k) number is K980177.

When did SUGITRON MODEL: IEC receive FDA 510(k) clearance?

SUGITRON MODEL: IEC received FDA 510(k) clearance on 1998-07-07, under 510(k) number K980177.

Who is the listed applicant for SUGITRON MODEL: IEC?

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

What is the FDA product code for SUGITRON MODEL: IEC?

The FDA product code for SUGITRON MODEL: IEC is GEI.

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Other records listing Ellman Intl., 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.

K013255SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RFK003126BIPOLAR TRIGGER-FLEX PROBEK001986SURGITRON IEC IIK001407SURGITRON IEC IIK001253SURGITRON IEC IIK992382SURGITRON RADIOLASE

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Related Devices (Code: GEI)

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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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