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FDA 510(k)

MEDELA VARIO 8/18/CI SECRETION & SURGICAL ASPIRATOR

K-Number: K061205 · 2006-06-21

ApplicantMedela AG
Decision Date2006-06-21
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDELA VARIO 8/18/CI SECRETION & SURGICAL ASPIRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Medela AG. It received FDA 510(k) clearance on 2006-06-21 under 510(k) number K061205. 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 VARIO 8/18/CI SECRETION & SURGICAL ASPIRATOR?

MEDELA VARIO 8/18/CI SECRETION & SURGICAL ASPIRATOR is a medical device that received FDA 510(k) clearance on 2006-06-21. The listed applicant is Medela AG. The 510(k) number is K061205.

When did MEDELA VARIO 8/18/CI SECRETION & SURGICAL ASPIRATOR receive FDA 510(k) clearance?

MEDELA VARIO 8/18/CI SECRETION & SURGICAL ASPIRATOR received FDA 510(k) clearance on 2006-06-21, under 510(k) number K061205.

Who is the listed applicant for MEDELA VARIO 8/18/CI SECRETION & SURGICAL ASPIRATOR?

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 VARIO 8/18/CI SECRETION & SURGICAL ASPIRATOR?

The FDA product code for MEDELA VARIO 8/18/CI SECRETION & SURGICAL ASPIRATOR 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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