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)

Power Infuser

K-Number: K172653 · 2018-07-18

ApplicantZOLL Medical Corporation
Decision Date2018-07-18
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Power Infuser is the device name listed in this FDA 510(k) record. The listed applicant is ZOLL Medical Corporation. It received FDA 510(k) clearance on 2018-07-18 under 510(k) number K172653. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Power Infuser?

Power Infuser is a medical device that received FDA 510(k) clearance on 2018-07-18. The listed applicant is ZOLL Medical Corporation. The 510(k) number is K172653.

When did Power Infuser receive FDA 510(k) clearance?

Power Infuser received FDA 510(k) clearance on 2018-07-18, under 510(k) number K172653.

Who is the listed applicant for Power Infuser?

The FDA 510(k) record lists ZOLL Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Power Infuser?

The FDA product code for Power Infuser is FRN.

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.

NCT07622472Remote Monitoring and Optimization of Heart Failure TherapyNOT_YET_RECRUITING

Other records listing ZOLL Medical Corporation 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.

PMA P160015Automated external defibrillators (non-wearable)PMA P160022Automated external defibrillators (non-wearable)PMA P160033Automated external defibrillators (non-wearable)PMA P890057VENTILATOR, HIGH FREQUENCYK233486731 Series VentilatorPMA P110024Combination compression/decompression manual chest pump with impedance respiratory valve

View all 12 devices →

Related Devices (Code: FRN)

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.

K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D CorpK252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc.K251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare CorporationK251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare CorporationK242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed CorporationK243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, Inc.

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.

↑