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FDA 510(k)

HYSTEROMED 100

K-Number: K930912 · 1994-10-17

ApplicantNorthgate Technologies, Inc.
Decision Date1994-10-17
Product CodeHIG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HYSTEROMED 100 is the device name listed in this FDA 510(k) record. The listed applicant is Northgate Technologies, Inc.. It received FDA 510(k) clearance on 1994-10-17 under 510(k) number K930912. The device is classified under product code HIG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYSTEROMED 100?

HYSTEROMED 100 is a medical device that received FDA 510(k) clearance on 1994-10-17. The listed applicant is Northgate Technologies, Inc.. The 510(k) number is K930912.

When did HYSTEROMED 100 receive FDA 510(k) clearance?

HYSTEROMED 100 received FDA 510(k) clearance on 1994-10-17, under 510(k) number K930912.

Who is the listed applicant for HYSTEROMED 100?

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

What is the FDA product code for HYSTEROMED 100?

The FDA product code for HYSTEROMED 100 is HIG.

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Related Devices (Code: HIG)

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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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