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FDA 510(k)

SUPRAFLOW CONSOLE

K-Number: K040239 · 2004-02-17

ApplicantNeomedix Corp.
Decision Date2004-02-17
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUPRAFLOW CONSOLE is the device name listed in this FDA 510(k) record. The listed applicant is Neomedix Corp.. It received FDA 510(k) clearance on 2004-02-17 under 510(k) number K040239. 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 SUPRAFLOW CONSOLE?

SUPRAFLOW CONSOLE is a medical device that received FDA 510(k) clearance on 2004-02-17. The listed applicant is Neomedix Corp.. The 510(k) number is K040239.

When did SUPRAFLOW CONSOLE receive FDA 510(k) clearance?

SUPRAFLOW CONSOLE received FDA 510(k) clearance on 2004-02-17, under 510(k) number K040239.

Who is the listed applicant for SUPRAFLOW CONSOLE?

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

What is the FDA product code for SUPRAFLOW CONSOLE?

The FDA product code for SUPRAFLOW CONSOLE is BTA.

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Other records listing Neomedix Corp. 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.

K061258TRABECTOME HIGH FREQUENCY GENERATOR/LPK040584NMX-1000K024304MICROSURGICAL BIPOLAR HANDPIECE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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