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FDA 510(k)

RADSTAR FAMILY, MODELS: RADSTAR 4343 & VARIATIONS

K-Number: K083645 · 2009-02-24

Applicant5 Star Medical, Inc.
Decision Date2009-02-24
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RADSTAR FAMILY, MODELS: RADSTAR 4343 & VARIATIONS is the device name listed in this FDA 510(k) record. The listed applicant is 5 Star Medical, Inc.. It received FDA 510(k) clearance on 2009-02-24 under 510(k) number K083645. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADSTAR FAMILY, MODELS: RADSTAR 4343 & VARIATIONS?

RADSTAR FAMILY, MODELS: RADSTAR 4343 & VARIATIONS is a medical device that received FDA 510(k) clearance on 2009-02-24. The listed applicant is 5 Star Medical, Inc.. The 510(k) number is K083645.

When did RADSTAR FAMILY, MODELS: RADSTAR 4343 & VARIATIONS receive FDA 510(k) clearance?

RADSTAR FAMILY, MODELS: RADSTAR 4343 & VARIATIONS received FDA 510(k) clearance on 2009-02-24, under 510(k) number K083645.

Who is the listed applicant for RADSTAR FAMILY, MODELS: RADSTAR 4343 & VARIATIONS?

The FDA 510(k) record lists 5 Star Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RADSTAR FAMILY, MODELS: RADSTAR 4343 & VARIATIONS?

The FDA product code for RADSTAR FAMILY, MODELS: RADSTAR 4343 & VARIATIONS is MQB.

Related Clinical Trials

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Other records listing 5 Star Medical, 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.

K944842ARTHROSCOPE

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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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