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FDA 510(k)

OMNIFLATOR 7640 MODEL 7-640-00

K-Number: K983326 · 1999-02-05

ApplicantNorthgate Technologies, Inc.
Decision Date1999-02-05
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

OMNIFLATOR 7640 MODEL 7-640-00 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 1999-02-05 under 510(k) number K983326. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNIFLATOR 7640 MODEL 7-640-00?

OMNIFLATOR 7640 MODEL 7-640-00 is a medical device that received FDA 510(k) clearance on 1999-02-05. The listed applicant is Northgate Technologies, Inc.. The 510(k) number is K983326.

When did OMNIFLATOR 7640 MODEL 7-640-00 receive FDA 510(k) clearance?

OMNIFLATOR 7640 MODEL 7-640-00 received FDA 510(k) clearance on 1999-02-05, under 510(k) number K983326.

Who is the listed applicant for OMNIFLATOR 7640 MODEL 7-640-00?

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 OMNIFLATOR 7640 MODEL 7-640-00?

The FDA product code for OMNIFLATOR 7640 MODEL 7-640-00 is HIF.

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Related Devices (Code: HIF)

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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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