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FDA 510(k)

NIASTAT

K-Number: K800066 · 1980-02-29

ApplicantInvivo Research Labs, Inc.
Decision Date1980-02-29
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NIASTAT is the device name listed in this FDA 510(k) record. The listed applicant is Invivo Research Labs, Inc.. It received FDA 510(k) clearance on 1980-02-29 under 510(k) number K800066. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIASTAT?

NIASTAT is a medical device that received FDA 510(k) clearance on 1980-02-29. The listed applicant is Invivo Research Labs, Inc.. The 510(k) number is K800066.

When did NIASTAT receive FDA 510(k) clearance?

NIASTAT received FDA 510(k) clearance on 1980-02-29, under 510(k) number K800066.

Who is the listed applicant for NIASTAT?

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

What is the FDA product code for NIASTAT?

The FDA product code for NIASTAT is DXN.

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Other records listing Invivo Research Labs, 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.

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Related Devices (Code: DXN)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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