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FDA 510(k)

BASIC AND DOMINANT FLEX SUCTION PUMPS

K-Number: K130123 · 2013-10-11

ApplicantMedela AG
Decision Date2013-10-11
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BASIC AND DOMINANT FLEX 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 2013-10-11 under 510(k) number K130123. 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 BASIC AND DOMINANT FLEX SUCTION PUMPS?

BASIC AND DOMINANT FLEX SUCTION PUMPS is a medical device that received FDA 510(k) clearance on 2013-10-11. The listed applicant is Medela AG. The 510(k) number is K130123.

When did BASIC AND DOMINANT FLEX SUCTION PUMPS receive FDA 510(k) clearance?

BASIC AND DOMINANT FLEX SUCTION PUMPS received FDA 510(k) clearance on 2013-10-11, under 510(k) number K130123.

Who is the listed applicant for BASIC AND DOMINANT FLEX 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 BASIC AND DOMINANT FLEX SUCTION PUMPS?

The FDA product code for BASIC AND DOMINANT FLEX SUCTION PUMPS 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.

K253629Momcozy Nasal Aspirator (BN007)Shenzhen Root Innovation Technology Co., Ltd.K260134Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)Shenzhen Root Innovation Technology Co., Ltd.K260892Suction Pump (SU-90)Shenzhen HugeMed Medical Technical Development Co., Ltd.K260473Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)Shenzhen Kingboom Technology Co., Ltd.K253107Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)Shenzhen Dongjiang Technology Co., Ltd.K260147Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)Shenzhen Kingboom 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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