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FDA 510(k)

ELECTRON WEDGE MODEL MT-EW-1000

K-Number: K981992 · 1998-12-15

ApplicantMed-Tec,Inc.
Decision Date1998-12-15
Product CodeIXI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ELECTRON WEDGE MODEL MT-EW-1000 is the device name listed in this FDA 510(k) record. The listed applicant is Med-Tec,Inc.. It received FDA 510(k) clearance on 1998-12-15 under 510(k) number K981992. The device is classified under product code IXI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTRON WEDGE MODEL MT-EW-1000?

ELECTRON WEDGE MODEL MT-EW-1000 is a medical device that received FDA 510(k) clearance on 1998-12-15. The listed applicant is Med-Tec,Inc.. The 510(k) number is K981992.

When did ELECTRON WEDGE MODEL MT-EW-1000 receive FDA 510(k) clearance?

ELECTRON WEDGE MODEL MT-EW-1000 received FDA 510(k) clearance on 1998-12-15, under 510(k) number K981992.

Who is the listed applicant for ELECTRON WEDGE MODEL MT-EW-1000?

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

What is the FDA product code for ELECTRON WEDGE MODEL MT-EW-1000?

The FDA product code for ELECTRON WEDGE MODEL MT-EW-1000 is IXI.

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Other records listing Med-Tec,Inc. as applicant

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Related Devices (Code: IXI)

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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