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)

SPUR INFANT/CHILD W/O PRESSURE-LIMITING VALVE

K-Number: K923762 · 1993-02-05

ApplicantAmbu, Inc.
Decision Date1993-02-05
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPUR INFANT/CHILD W/O PRESSURE-LIMITING VALVE is the device name listed in this FDA 510(k) record. The listed applicant is Ambu, Inc.. It received FDA 510(k) clearance on 1993-02-05 under 510(k) number K923762. The device is classified under product code BTM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPUR INFANT/CHILD W/O PRESSURE-LIMITING VALVE?

SPUR INFANT/CHILD W/O PRESSURE-LIMITING VALVE is a medical device that received FDA 510(k) clearance on 1993-02-05. The listed applicant is Ambu, Inc.. The 510(k) number is K923762.

When did SPUR INFANT/CHILD W/O PRESSURE-LIMITING VALVE receive FDA 510(k) clearance?

SPUR INFANT/CHILD W/O PRESSURE-LIMITING VALVE received FDA 510(k) clearance on 1993-02-05, under 510(k) number K923762.

Who is the listed applicant for SPUR INFANT/CHILD W/O PRESSURE-LIMITING VALVE?

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 SPUR INFANT/CHILD W/O PRESSURE-LIMITING VALVE?

The FDA product code for SPUR INFANT/CHILD W/O PRESSURE-LIMITING VALVE is BTM.

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: BTM)

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.

K251631The BAG manual resuscitator and accessoriesLaerdal Medical ASK243861butterflyBVMCompact Medical, Inc.K221841EOlife®ArcheonK212905Sotair DeviceSafe Bvm CorporationK210288Disposable Manual ResuscitatorXiamen Compower Medical Tech. Co., Ltd.K181583Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20Flexicare Medical Limited.

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.

↑