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FDA 510(k)

MEDELA THOPAZ, MODEL 200 0288

K-Number: K080212 · 2008-07-23

ApplicantMedela AG
Decision Date2008-07-23
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDELA THOPAZ, MODEL 200 0288 is the device name listed in this FDA 510(k) record. The listed applicant is Medela AG. It received FDA 510(k) clearance on 2008-07-23 under 510(k) number K080212. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDELA THOPAZ, MODEL 200 0288?

MEDELA THOPAZ, MODEL 200 0288 is a medical device that received FDA 510(k) clearance on 2008-07-23. The listed applicant is Medela AG. The 510(k) number is K080212.

When did MEDELA THOPAZ, MODEL 200 0288 receive FDA 510(k) clearance?

MEDELA THOPAZ, MODEL 200 0288 received FDA 510(k) clearance on 2008-07-23, under 510(k) number K080212.

Who is the listed applicant for MEDELA THOPAZ, MODEL 200 0288?

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

What is the FDA product code for MEDELA THOPAZ, MODEL 200 0288?

The FDA product code for MEDELA THOPAZ, MODEL 200 0288 is BTA.

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Related Devices (Code: BTA)

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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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