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FDA 510(k)

ACUMED RADIUS ROD

K-Number: K933361 · 1994-02-22

ApplicantAcu Med, Inc.
Decision Date1994-02-22
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACUMED RADIUS ROD is the device name listed in this FDA 510(k) record. The listed applicant is Acu Med, Inc.. It received FDA 510(k) clearance on 1994-02-22 under 510(k) number K933361. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUMED RADIUS ROD?

ACUMED RADIUS ROD is a medical device that received FDA 510(k) clearance on 1994-02-22. The listed applicant is Acu Med, Inc.. The 510(k) number is K933361.

When did ACUMED RADIUS ROD receive FDA 510(k) clearance?

ACUMED RADIUS ROD received FDA 510(k) clearance on 1994-02-22, under 510(k) number K933361.

Who is the listed applicant for ACUMED RADIUS ROD?

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

What is the FDA product code for ACUMED RADIUS ROD?

The FDA product code for ACUMED RADIUS ROD is HSB.

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Other records listing Acu Med, Inc. as applicant

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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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