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FDA 510(k)

ALPHA SUPER KART

K-Number: K853766 · 1985-11-20

ApplicantAlpha Unlimited, Inc.
Decision Date1985-11-20
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ALPHA SUPER KART 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 1985-11-20 under 510(k) number K853766. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALPHA SUPER KART?

ALPHA SUPER KART is a medical device that received FDA 510(k) clearance on 1985-11-20. The listed applicant is Alpha Unlimited, Inc.. The 510(k) number is K853766.

When did ALPHA SUPER KART receive FDA 510(k) clearance?

ALPHA SUPER KART received FDA 510(k) clearance on 1985-11-20, under 510(k) number K853766.

Who is the listed applicant for ALPHA SUPER KART?

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 SUPER KART?

The FDA product code for ALPHA SUPER KART is INI.

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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)K893429ALPHA CONDORK893428ALPHA SHOPPERK893248ALPHA MALLARDK841921ALPHA PLUS 1K841911ALPHA PUSH KART

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Related Devices (Code: INI)

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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