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FDA 510(k)

ACI PULSATING VACUUM PUMP SYSTEM

K-Number: K954286 · 1995-11-29

ApplicantAdvanced Cytometrix, Inc.
Decision Date1995-11-29
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACI PULSATING VACUUM PUMP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Cytometrix, Inc.. It received FDA 510(k) clearance on 1995-11-29 under 510(k) number K954286. 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 ACI PULSATING VACUUM PUMP SYSTEM?

ACI PULSATING VACUUM PUMP SYSTEM is a medical device that received FDA 510(k) clearance on 1995-11-29. The listed applicant is Advanced Cytometrix, Inc.. The 510(k) number is K954286.

When did ACI PULSATING VACUUM PUMP SYSTEM receive FDA 510(k) clearance?

ACI PULSATING VACUUM PUMP SYSTEM received FDA 510(k) clearance on 1995-11-29, under 510(k) number K954286.

Who is the listed applicant for ACI PULSATING VACUUM PUMP SYSTEM?

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

What is the FDA product code for ACI PULSATING VACUUM PUMP SYSTEM?

The FDA product code for ACI PULSATING VACUUM PUMP SYSTEM is BTA.

Related Clinical Trials

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.

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Other records listing Advanced Cytometrix, 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.

K954264ACI SINGLE LUMEN BIOPSY NEEDLEK954287ACI FINE NEEDLE ASPIRATION BIOPSY KIT

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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