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)

PUMP & DETECTOR

K-Number: K813455 · 1982-01-05

ApplicantMedlog GmbH Marketing Services
Decision Date1982-01-05
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PUMP & DETECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Medlog GmbH Marketing Services. It received FDA 510(k) clearance on 1982-01-05 under 510(k) number K813455. 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 PUMP & DETECTOR?

PUMP & DETECTOR is a medical device that received FDA 510(k) clearance on 1982-01-05. The listed applicant is Medlog GmbH Marketing Services. The 510(k) number is K813455.

When did PUMP & DETECTOR receive FDA 510(k) clearance?

PUMP & DETECTOR received FDA 510(k) clearance on 1982-01-05, under 510(k) number K813455.

Who is the listed applicant for PUMP & DETECTOR?

The FDA 510(k) record lists Medlog GmbH Marketing Services as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PUMP & DETECTOR?

The FDA product code for PUMP & DETECTOR 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.

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 Medlog GmbH Marketing Services 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.

K832086USE 77 ULTRASONIC NEBULIZERK831325NUTROMATK830913MINITROP AEROSAL, PRODOMO AEROSAL ANDK810155DOP 84

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.K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare CorporationK251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter 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.

↑