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 PORTABLE SUCTION UNIT

K-Number: K932031 · 1995-05-05

ApplicantAmbu, Inc.
Decision Date1995-05-05
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AMBU PORTABLE SUCTION UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Ambu, Inc.. It received FDA 510(k) clearance on 1995-05-05 under 510(k) number K932031. 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 AMBU PORTABLE SUCTION UNIT?

AMBU PORTABLE SUCTION UNIT is a medical device that received FDA 510(k) clearance on 1995-05-05. The listed applicant is Ambu, Inc.. The 510(k) number is K932031.

When did AMBU PORTABLE SUCTION UNIT receive FDA 510(k) clearance?

AMBU PORTABLE SUCTION UNIT received FDA 510(k) clearance on 1995-05-05, under 510(k) number K932031.

Who is the listed applicant for AMBU PORTABLE SUCTION UNIT?

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 PORTABLE SUCTION UNIT?

The FDA product code for AMBU PORTABLE SUCTION UNIT 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.

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: 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.

↑