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FDA 510(k)

SIMPLEABI

K-Number: K110628 · 2011-05-12

ApplicantNewman Medical
Decision Date2011-05-12
Product CodeJAF
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SIMPLEABI is the device name listed in this FDA 510(k) record. The listed applicant is Newman Medical. It received FDA 510(k) clearance on 2011-05-12 under 510(k) number K110628. The device is classified under product code JAF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIMPLEABI?

SIMPLEABI is a medical device that received FDA 510(k) clearance on 2011-05-12. The listed applicant is Newman Medical. The 510(k) number is K110628.

When did SIMPLEABI receive FDA 510(k) clearance?

SIMPLEABI received FDA 510(k) clearance on 2011-05-12, under 510(k) number K110628.

Who is the listed applicant for SIMPLEABI?

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

What is the FDA product code for SIMPLEABI?

The FDA product code for SIMPLEABI is JAF.

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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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