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FDA 510(k)

SPECBOARD JR.

K-Number: K123414 · 2013-01-11

ApplicantMacbrud Corp., Medical Division
Decision Date2013-01-11
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SPECBOARD JR. is the device name listed in this FDA 510(k) record. The listed applicant is Macbrud Corp., Medical Division. It received FDA 510(k) clearance on 2013-01-11 under 510(k) number K123414. The device is classified under product code IZH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECBOARD JR.?

SPECBOARD JR. is a medical device that received FDA 510(k) clearance on 2013-01-11. The listed applicant is Macbrud Corp., Medical Division. The 510(k) number is K123414.

When did SPECBOARD JR. receive FDA 510(k) clearance?

SPECBOARD JR. received FDA 510(k) clearance on 2013-01-11, under 510(k) number K123414.

Who is the listed applicant for SPECBOARD JR.?

The FDA 510(k) record lists Macbrud Corp., Medical Division as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPECBOARD JR.?

The FDA product code for SPECBOARD JR. is IZH.

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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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