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FDA 510(k)

MEDELA VARIO SUCTION PUMPS

K-Number: K061435 · 2006-06-08

ApplicantMedela AG
Decision Date2006-06-08
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDELA VARIO SUCTION PUMPS is the device name listed in this FDA 510(k) record. The listed applicant is Medela AG. It received FDA 510(k) clearance on 2006-06-08 under 510(k) number K061435. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDELA VARIO SUCTION PUMPS?

MEDELA VARIO SUCTION PUMPS is a medical device that received FDA 510(k) clearance on 2006-06-08. The listed applicant is Medela AG. The 510(k) number is K061435.

When did MEDELA VARIO SUCTION PUMPS receive FDA 510(k) clearance?

MEDELA VARIO SUCTION PUMPS received FDA 510(k) clearance on 2006-06-08, under 510(k) number K061435.

Who is the listed applicant for MEDELA VARIO SUCTION PUMPS?

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 SUCTION PUMPS?

The FDA product code for MEDELA VARIO SUCTION PUMPS is OMP.

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Other records listing Medela AG as applicant

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Related Devices (Code: OMP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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