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FDA 510(k)

MEDELA THOPAZ

K-Number: K130210 · 2013-03-15

ApplicantMedela AG
Decision Date2013-03-15
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDELA THOPAZ is the device name listed in this FDA 510(k) record. The listed applicant is Medela AG. It received FDA 510(k) clearance on 2013-03-15 under 510(k) number K130210. 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?

MEDELA THOPAZ is a medical device that received FDA 510(k) clearance on 2013-03-15. The listed applicant is Medela AG. The 510(k) number is K130210.

When did MEDELA THOPAZ receive FDA 510(k) clearance?

MEDELA THOPAZ received FDA 510(k) clearance on 2013-03-15, under 510(k) number K130210.

Who is the listed applicant for MEDELA THOPAZ?

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?

The FDA product code for MEDELA THOPAZ 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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