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FDA 510(k)

ALPHA 4 X 4

K-Number: K841912 · 1984-05-23

ApplicantAlpha Unlimited, Inc.
Decision Date1984-05-23
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ALPHA 4 X 4 is the device name listed in this FDA 510(k) record. The listed applicant is Alpha Unlimited, Inc.. It received FDA 510(k) clearance on 1984-05-23 under 510(k) number K841912. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALPHA 4 X 4?

ALPHA 4 X 4 is a medical device that received FDA 510(k) clearance on 1984-05-23. The listed applicant is Alpha Unlimited, Inc.. The 510(k) number is K841912.

When did ALPHA 4 X 4 receive FDA 510(k) clearance?

ALPHA 4 X 4 received FDA 510(k) clearance on 1984-05-23, under 510(k) number K841912.

Who is the listed applicant for ALPHA 4 X 4?

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

What is the FDA product code for ALPHA 4 X 4?

The FDA product code for ALPHA 4 X 4 is ITI.

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Other records listing Alpha Unlimited, 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.

K894646#556 DISPOSABLE UMBILICAL CORD CLAMP (2)K893428ALPHA SHOPPERK893429ALPHA CONDORK893248ALPHA MALLARDK853766ALPHA SUPER KARTK841921ALPHA PLUS 1

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Related Devices (Code: ITI)

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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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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