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FDA 510(k)

HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP)

K-Number: K101538 · 2010-11-05

ApplicantPhilips Electronics UK Limited
Decision Date2010-11-05
Product CodeHGY
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP) is the device name listed in this FDA 510(k) record. The listed applicant is Philips Electronics UK Limited. It received FDA 510(k) clearance on 2010-11-05 under 510(k) number K101538. The device is classified under product code HGY. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP)?

HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP) is a medical device that received FDA 510(k) clearance on 2010-11-05. The listed applicant is Philips Electronics UK Limited. The 510(k) number is K101538.

When did HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP) receive FDA 510(k) clearance?

HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP) received FDA 510(k) clearance on 2010-11-05, under 510(k) number K101538.

Who is the listed applicant for HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP)?

The FDA 510(k) record lists Philips Electronics UK Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP)?

The FDA product code for HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP) is HGY.

Related Clinical Trials

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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Other records listing Philips Electronics UK Limited as applicant

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.

K100495PHILIPS AVENT DIGITAL THERMOMETER SET, MODEL SCH540K090167PHILIPS AVENT CLASSIC STAGE 2 AND 3 TEETHER, MODEL SCF882/01, SCF884/01, PHILIPS AVENT ANIMAL STAGE 2 AND 3 TEETHER,

Related Devices (Code: HGY)

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.

K032845EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187The First Years, Inc.K013226EVENFLO COMFORT EASE MANUAL BREAST PUMP KITEvenflo Company, Inc.K011519AMEDA HYGIENIKITHollister, Inc.K971231WHITE RIVER MINI MANUAL BREAST PUMPWhite River ConceptsK962828EVERT-ITGenesis Industries, Inc.K952034MEDELA'S FOOT PUMPMedela, Inc.

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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