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)

MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242

K-Number: K982624 · 1998-10-26

ApplicantMed-Tec,Inc.
Decision Date1998-10-26
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242 is the device name listed in this FDA 510(k) record. The listed applicant is Med-Tec,Inc.. It received FDA 510(k) clearance on 1998-10-26 under 510(k) number K982624. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242?

MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242 is a medical device that received FDA 510(k) clearance on 1998-10-26. The listed applicant is Med-Tec,Inc.. The 510(k) number is K982624.

When did MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242 receive FDA 510(k) clearance?

MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242 received FDA 510(k) clearance on 1998-10-26, under 510(k) number K982624.

Who is the listed applicant for MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242?

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

What is the FDA product code for MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242?

The FDA product code for MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242 is IYE.

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 Med-Tec,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.

K034054PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100K031866MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DACK021360SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000K023293MED-TEC BELLYBOARD, MODELS MT-BBA-01 & MT-BBA-02K013875MED-TEC COMPENSATOR BLOCK CUTTER SOFTWAREK001052MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX

View all 8 devices →

Related Devices (Code: IYE)

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.

K261865AerFrame™ Alignment Laser Box (LBV2)Stabilix, LLCK261718EZFluence (RADEZ V2)Radformation, Inc.K260733MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd.K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SAK253004LUNA 3DLap GmbH Laser Applikationen

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.

↑