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)

DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247

K-Number: K061107 · 2006-08-08

ApplicantThermo Electron OY
Decision Date2006-08-08
Product CodeCEM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247 is the device name listed in this FDA 510(k) record. The listed applicant is Thermo Electron OY. It received FDA 510(k) clearance on 2006-08-08 under 510(k) number K061107. The device is classified under product code CEM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247?

DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247 is a medical device that received FDA 510(k) clearance on 2006-08-08. The listed applicant is Thermo Electron OY. The 510(k) number is K061107.

When did DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247 receive FDA 510(k) clearance?

DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247 received FDA 510(k) clearance on 2006-08-08, under 510(k) number K061107.

Who is the listed applicant for DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247?

The FDA 510(k) record lists Thermo Electron OY as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247?

The FDA product code for DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247 is CEM.

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 Thermo Electron OY 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.

K063145PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLSK063705LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROLK063131CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLSK063838LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGHK063086TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLSK063209HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL

View all 9 devices →

Related Devices (Code: CEM)

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.

K253491ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutionsRoche DiagnosticsK241037ABL90 FLEX PLUS SystemRadiometer Medicals ApsK220396EasyStat 300Medica CorporationK230890ISE ElectrodesRandox Laboratories, Ltd.K200544SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+Diamond Diagnostics, Inc.K121012FLEXLAB 3.6, ACCELERATOR A3600Inpeco S.P.A.

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.

↑