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FDA 510(k)

MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057

K-Number: K021368 · 2002-05-15

ApplicantMedela AG
Decision Date2002-05-15
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057 is the device name listed in this FDA 510(k) record. The listed applicant is Medela AG. It received FDA 510(k) clearance on 2002-05-15 under 510(k) number K021368. 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 BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057?

MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057 is a medical device that received FDA 510(k) clearance on 2002-05-15. The listed applicant is Medela AG. The 510(k) number is K021368.

When did MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057 receive FDA 510(k) clearance?

MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057 received FDA 510(k) clearance on 2002-05-15, under 510(k) number K021368.

Who is the listed applicant for MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057?

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 BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057?

The FDA product code for MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057 is BTA.

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Related Devices (Code: BTA)

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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