Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AMBU HAND POWER SUCTION PUMP

K-Number: K992902 · 1999-10-25

ApplicantAmbu, Inc.
Decision Date1999-10-25
Product CodeBSY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AMBU HAND POWER SUCTION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Ambu, Inc.. It received FDA 510(k) clearance on 1999-10-25 under 510(k) number K992902. The device is classified under product code BSY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMBU HAND POWER SUCTION PUMP?

AMBU HAND POWER SUCTION PUMP is a medical device that received FDA 510(k) clearance on 1999-10-25. The listed applicant is Ambu, Inc.. The 510(k) number is K992902.

When did AMBU HAND POWER SUCTION PUMP receive FDA 510(k) clearance?

AMBU HAND POWER SUCTION PUMP received FDA 510(k) clearance on 1999-10-25, under 510(k) number K992902.

Who is the listed applicant for AMBU HAND POWER SUCTION PUMP?

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

What is the FDA product code for AMBU HAND POWER SUCTION PUMP?

The FDA product code for AMBU HAND POWER SUCTION PUMP is BSY.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ambu, 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.

K051529AMBU NEUROLINE GROUNDK042682AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATORK042843AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORSK041734AMBU DISPOSABLE ECG ELECTRODEK040991AMBU DISPOSABLE PRESSURE MANOMETERK041026AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S

View all 33 devices →

Related Devices (Code: BSY)

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.

K031997MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEMMallinckrodt Dar S.R.L.K982945DUAL PURPOSE CLOSED CATHETERSpirit Medical Systems, Inc.K981910SUCTION CATHETERNi-Med, Inc.K972258HI-CARE CLOSED SUCTION SYSTEMMallinckrodt MedicalK973199AMSINO SUCTION CATHETERAmsino Intl., Inc.K961707TRACH-EZE CLOSED VENTILATION SUCTION SYSTEMSorenson Critical Care

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.

↑