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FDA 510(k)

ALPHA MASS STORAGE CARDULE 1895

K-Number: K834597 · 1984-04-17

ApplicantSpacelabs, Inc.
Decision Date1984-04-17
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ALPHA MASS STORAGE CARDULE 1895 is the device name listed in this FDA 510(k) record. The listed applicant is Spacelabs, Inc.. It received FDA 510(k) clearance on 1984-04-17 under 510(k) number K834597. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALPHA MASS STORAGE CARDULE 1895?

ALPHA MASS STORAGE CARDULE 1895 is a medical device that received FDA 510(k) clearance on 1984-04-17. The listed applicant is Spacelabs, Inc.. The 510(k) number is K834597.

When did ALPHA MASS STORAGE CARDULE 1895 receive FDA 510(k) clearance?

ALPHA MASS STORAGE CARDULE 1895 received FDA 510(k) clearance on 1984-04-17, under 510(k) number K834597.

Who is the listed applicant for ALPHA MASS STORAGE CARDULE 1895?

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 ALPHA MASS STORAGE CARDULE 1895?

The FDA product code for ALPHA MASS STORAGE CARDULE 1895 is DSI.

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Other records listing Spacelabs, Inc. as applicant

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Related Devices (Code: DSI)

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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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