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FDA 510(k)

ABBOTT ACCLAIM ENCORE, MODEL 12237

K-Number: K011096 · 2001-05-01

ApplicantAbbott Laboratories
Decision Date2001-05-01
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ABBOTT ACCLAIM ENCORE, MODEL 12237 is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2001-05-01 under 510(k) number K011096. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABBOTT ACCLAIM ENCORE, MODEL 12237?

ABBOTT ACCLAIM ENCORE, MODEL 12237 is a medical device that received FDA 510(k) clearance on 2001-05-01. The listed applicant is Abbott Laboratories. The 510(k) number is K011096.

When did ABBOTT ACCLAIM ENCORE, MODEL 12237 receive FDA 510(k) clearance?

ABBOTT ACCLAIM ENCORE, MODEL 12237 received FDA 510(k) clearance on 2001-05-01, under 510(k) number K011096.

Who is the listed applicant for ABBOTT ACCLAIM ENCORE, MODEL 12237?

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

What is the FDA product code for ABBOTT ACCLAIM ENCORE, MODEL 12237?

The FDA product code for ABBOTT ACCLAIM ENCORE, MODEL 12237 is FRN.

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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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