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FDA 510(k)

EGNELL UNIVERSAL SUCTION PUMP

K-Number: K853909 · 1985-11-25

ApplicantEgnell, Inc.
Decision Date1985-11-25
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

EGNELL UNIVERSAL SUCTION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Egnell, Inc.. It received FDA 510(k) clearance on 1985-11-25 under 510(k) number K853909. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the EGNELL UNIVERSAL SUCTION PUMP?

EGNELL UNIVERSAL SUCTION PUMP is a medical device that received FDA 510(k) clearance on 1985-11-25. The listed applicant is Egnell, Inc.. The 510(k) number is K853909.

When did EGNELL UNIVERSAL SUCTION PUMP receive FDA 510(k) clearance?

EGNELL UNIVERSAL SUCTION PUMP received FDA 510(k) clearance on 1985-11-25, under 510(k) number K853909.

Who is the listed applicant for EGNELL UNIVERSAL SUCTION PUMP?

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

What is the FDA product code for EGNELL UNIVERSAL SUCTION PUMP?

The FDA product code for EGNELL UNIVERSAL SUCTION PUMP 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 Egnell, 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.

K853917EGNELL COMPACT SUCTION PUMPK844307EGNELL-LACT B BATTERY-OPERATED BREAST PUMPK840526AMETHERMK834335AMEDA PHOTOTHERAPY LAMP FOR NEWBORNK832637AMEDA NEONATAL RESUSCITATION UNIT-K813312UNIVERSAL SUCTION PUMP TYPE EUS

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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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