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FDA 510(k)

Rumble Tuff Electric Breast Pump

K-Number: K200712 · 2020-04-17

ApplicantA Cute Baby, Inc.
Decision Date2020-04-17
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Rumble Tuff Electric Breast Pump is the device name listed in this FDA 510(k) record. The listed applicant is A Cute Baby, Inc.. It received FDA 510(k) clearance on 2020-04-17 under 510(k) number K200712. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rumble Tuff Electric Breast Pump?

Rumble Tuff Electric Breast Pump is a medical device that received FDA 510(k) clearance on 2020-04-17. The listed applicant is A Cute Baby, Inc.. The 510(k) number is K200712.

When did Rumble Tuff Electric Breast Pump receive FDA 510(k) clearance?

Rumble Tuff Electric Breast Pump received FDA 510(k) clearance on 2020-04-17, under 510(k) number K200712.

Who is the listed applicant for Rumble Tuff Electric Breast Pump?

The FDA 510(k) record lists A Cute Baby, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rumble Tuff Electric Breast Pump?

The FDA product code for Rumble Tuff Electric Breast Pump is HGX.

Other records listing A Cute Baby, Inc. 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.

K252583Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220)

Related Devices (Code: HGX)

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.

K260259DiscreetDuo™ Flow Wearable Breast Pump (Model S3)Shenzhen TPH Technology Co., Ltd.K261199Wearable Breast Pump (Model S32A)Shenzhen TPH Technology Co., Ltd.K250070Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)Shenzhen Changkun Technology Co., Ltd.K261025Wearable breast pump (QY-101, QY-102, QY-108)Shenzhen Qinyi Electronic Technology Co., Ltd.K254254Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)Shenzhen Root Innovation Technology Co., Ltd.K260538Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )Shenzhen Root Innovation Technology Co., Ltd.

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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