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FDA 510(k)

HYDROLOGY 5000

K-Number: K955339 · 1996-03-13

ApplicantNorthgate Technologies, Inc.
Decision Date1996-03-13
Product CodeGBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HYDROLOGY 5000 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 1996-03-13 under 510(k) number K955339. The device is classified under product code GBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDROLOGY 5000?

HYDROLOGY 5000 is a medical device that received FDA 510(k) clearance on 1996-03-13. The listed applicant is Northgate Technologies, Inc.. The 510(k) number is K955339.

When did HYDROLOGY 5000 receive FDA 510(k) clearance?

HYDROLOGY 5000 received FDA 510(k) clearance on 1996-03-13, under 510(k) number K955339.

Who is the listed applicant for HYDROLOGY 5000?

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 HYDROLOGY 5000?

The FDA product code for HYDROLOGY 5000 is GBX.

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Other records listing Northgate Technologies, Inc. as applicant

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Related Devices (Code: GBX)

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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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