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FDA 510(k)

POLARUS AF ROD

K-Number: K962091 · 1996-07-24

ApplicantAcu Med, Inc.
Decision Date1996-07-24
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

POLARUS AF 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 1996-07-24 under 510(k) number K962091. 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 POLARUS AF ROD?

POLARUS AF ROD is a medical device that received FDA 510(k) clearance on 1996-07-24. The listed applicant is Acu Med, Inc.. The 510(k) number is K962091.

When did POLARUS AF ROD receive FDA 510(k) clearance?

POLARUS AF ROD received FDA 510(k) clearance on 1996-07-24, under 510(k) number K962091.

Who is the listed applicant for POLARUS AF 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 POLARUS AF ROD?

The FDA product code for POLARUS AF 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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