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)

NEOPOP INFANT RESUSCITATOR WITH FLOW METER

K-Number: K102649 · 2011-01-06

ApplicantNeoforce Group, Inc.
Decision Date2011-01-06
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NEOPOP INFANT RESUSCITATOR WITH FLOW METER is the device name listed in this FDA 510(k) record. The listed applicant is Neoforce Group, Inc.. It received FDA 510(k) clearance on 2011-01-06 under 510(k) number K102649. 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 NEOPOP INFANT RESUSCITATOR WITH FLOW METER?

NEOPOP INFANT RESUSCITATOR WITH FLOW METER is a medical device that received FDA 510(k) clearance on 2011-01-06. The listed applicant is Neoforce Group, Inc.. The 510(k) number is K102649.

When did NEOPOP INFANT RESUSCITATOR WITH FLOW METER receive FDA 510(k) clearance?

NEOPOP INFANT RESUSCITATOR WITH FLOW METER received FDA 510(k) clearance on 2011-01-06, under 510(k) number K102649.

Who is the listed applicant for NEOPOP INFANT RESUSCITATOR WITH FLOW METER?

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

What is the FDA product code for NEOPOP INFANT RESUSCITATOR WITH FLOW METER?

The FDA product code for NEOPOP INFANT RESUSCITATOR WITH FLOW METER 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 Neoforce Group, 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.

K110119PRESSURE MANOMETERK103833NEOPIP PATIENT CIRCUIT WITH PEEPK092085ISPIRA RESUSCITATION UNITK072021NEOPIP INFANT RESUSCITATORK070416NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEPK061280V-2200 INFANT INCUBATOR

View all 7 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.

↑