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)

BELMONT UNIT, MODEL 6000 SERIES AND 7500 SERIES

K-Number: K983661 · 1999-01-12

ApplicantBelmont Equipment Corp.
Decision Date1999-01-12
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BELMONT UNIT, MODEL 6000 SERIES AND 7500 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Belmont Equipment Corp.. It received FDA 510(k) clearance on 1999-01-12 under 510(k) number K983661. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BELMONT UNIT, MODEL 6000 SERIES AND 7500 SERIES?

BELMONT UNIT, MODEL 6000 SERIES AND 7500 SERIES is a medical device that received FDA 510(k) clearance on 1999-01-12. The listed applicant is Belmont Equipment Corp.. The 510(k) number is K983661.

When did BELMONT UNIT, MODEL 6000 SERIES AND 7500 SERIES receive FDA 510(k) clearance?

BELMONT UNIT, MODEL 6000 SERIES AND 7500 SERIES received FDA 510(k) clearance on 1999-01-12, under 510(k) number K983661.

Who is the listed applicant for BELMONT UNIT, MODEL 6000 SERIES AND 7500 SERIES?

The FDA 510(k) record lists Belmont Equipment Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BELMONT UNIT, MODEL 6000 SERIES AND 7500 SERIES?

The FDA product code for BELMONT UNIT, MODEL 6000 SERIES AND 7500 SERIES is EIA.

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 Belmont Equipment Corp. 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.

K000799BELMONT UNIT, MODEL 2000 SERIESK963699BELRAY/MODEL 096, DENTAL INTRAORAL X-RAYK900681PANORAMIC MODEL X-CALIBER X-RAYK874238MODEL 2001 CP, PHOTON I, DENTAL, INTRAORAL X-RAYK870300BELMONT, PODIATRY X-RAY - REMEX, MODEL PD75K861328NEW BELMONT MODEL, MC-5 DENTAL, INTRAORAL X-RAY

View all 12 devices →

Related Devices (Code: EIA)

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.

K251544Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)Lakong Medical Devices Co., Ltd.K251626Midmark Dental Delivery SystemMidmark CorporationK251491K5 Cart, K5 Mount, K5 SwingOsstem Implant Company., Ltd. Chair BusinessK243130Integral Dental UnitGuangdong Yadeng Medical Apparatus Co., Ltd.,K242611Integral Dental UnitsMipont Medical Equipment Co., Ltd.K250473Dental Delivery System Series 5 and Dental Delivery System Series 5 PlusDci International, LLC

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.

↑