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FDA 510(k)

SMARTSUCTION HARMONY DEVICE

K-Number: K052626 · 2005-10-05

ApplicantHaemonetics Corp.
Decision Date2005-10-05
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SMARTSUCTION HARMONY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Haemonetics Corp.. It received FDA 510(k) clearance on 2005-10-05 under 510(k) number K052626. 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 SMARTSUCTION HARMONY DEVICE?

SMARTSUCTION HARMONY DEVICE is a medical device that received FDA 510(k) clearance on 2005-10-05. The listed applicant is Haemonetics Corp.. The 510(k) number is K052626.

When did SMARTSUCTION HARMONY DEVICE receive FDA 510(k) clearance?

SMARTSUCTION HARMONY DEVICE received FDA 510(k) clearance on 2005-10-05, under 510(k) number K052626.

Who is the listed applicant for SMARTSUCTION HARMONY DEVICE?

The FDA 510(k) record lists Haemonetics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMARTSUCTION HARMONY DEVICE?

The FDA product code for SMARTSUCTION HARMONY DEVICE is BTA.

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Other records listing Haemonetics Corp. 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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