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FDA 510(k)

LOCAL REPORT GENERATOR

K-Number: K904318 · 1990-12-18

ApplicantSpacelabs, Inc.
Decision Date1990-12-18
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LOCAL REPORT GENERATOR is the device name listed in this FDA 510(k) record. The listed applicant is Spacelabs, Inc.. It received FDA 510(k) clearance on 1990-12-18 under 510(k) number K904318. 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 LOCAL REPORT GENERATOR?

LOCAL REPORT GENERATOR is a medical device that received FDA 510(k) clearance on 1990-12-18. The listed applicant is Spacelabs, Inc.. The 510(k) number is K904318.

When did LOCAL REPORT GENERATOR receive FDA 510(k) clearance?

LOCAL REPORT GENERATOR received FDA 510(k) clearance on 1990-12-18, under 510(k) number K904318.

Who is the listed applicant for LOCAL REPORT GENERATOR?

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

What is the FDA product code for LOCAL REPORT GENERATOR?

The FDA product code for LOCAL REPORT GENERATOR is DXN.

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Other records listing Spacelabs, 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

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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