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FDA 510(k)

UNIVERSAL SUCTION PUMP TYPE EUS

K-Number: K813312 · 1981-12-31

ApplicantEgnell, Inc.
Decision Date1981-12-31
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL SUCTION PUMP TYPE EUS is the device name listed in this FDA 510(k) record. The listed applicant is Egnell, Inc.. It received FDA 510(k) clearance on 1981-12-31 under 510(k) number K813312. 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 UNIVERSAL SUCTION PUMP TYPE EUS?

UNIVERSAL SUCTION PUMP TYPE EUS is a medical device that received FDA 510(k) clearance on 1981-12-31. The listed applicant is Egnell, Inc.. The 510(k) number is K813312.

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

UNIVERSAL SUCTION PUMP TYPE EUS received FDA 510(k) clearance on 1981-12-31, under 510(k) number K813312.

Who is the listed applicant for UNIVERSAL SUCTION PUMP TYPE EUS?

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 UNIVERSAL SUCTION PUMP TYPE EUS?

The FDA product code for UNIVERSAL SUCTION PUMP TYPE EUS is BTA.

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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 PUMPK853909EGNELL UNIVERSAL SUCTION PUMPK844307EGNELL-LACT B BATTERY-OPERATED BREAST PUMPK840526AMETHERMK834335AMEDA PHOTOTHERAPY LAMP FOR NEWBORNK832637AMEDA NEONATAL RESUSCITATION UNIT-

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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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