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FDA 510(k)

PIONEER U601 SERIES ASPIRATOR

K-Number: K052650 · 2005-11-04

ApplicantMerits Health Products Co., Ltd.
Decision Date2005-11-04
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PIONEER U601 SERIES ASPIRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Merits Health Products Co., Ltd.. It received FDA 510(k) clearance on 2005-11-04 under 510(k) number K052650. 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 PIONEER U601 SERIES ASPIRATOR?

PIONEER U601 SERIES ASPIRATOR is a medical device that received FDA 510(k) clearance on 2005-11-04. The listed applicant is Merits Health Products Co., Ltd.. The 510(k) number is K052650.

When did PIONEER U601 SERIES ASPIRATOR receive FDA 510(k) clearance?

PIONEER U601 SERIES ASPIRATOR received FDA 510(k) clearance on 2005-11-04, under 510(k) number K052650.

Who is the listed applicant for PIONEER U601 SERIES ASPIRATOR?

The FDA 510(k) record lists Merits Health Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PIONEER U601 SERIES ASPIRATOR?

The FDA product code for PIONEER U601 SERIES ASPIRATOR is BTA.

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Other records listing Merits Health Products Co., Ltd. as applicant

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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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