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FDA 510(k)

EMS SURFACE MOUNT SCALER

K-Number: K991874 · 1999-07-30

Applicant(Ems Sa) Electro Medical Systems
Decision Date1999-07-30
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EMS SURFACE MOUNT SCALER is the device name listed in this FDA 510(k) record. The listed applicant is (Ems Sa) Electro Medical Systems. It received FDA 510(k) clearance on 1999-07-30 under 510(k) number K991874. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMS SURFACE MOUNT SCALER?

EMS SURFACE MOUNT SCALER is a medical device that received FDA 510(k) clearance on 1999-07-30. The listed applicant is (Ems Sa) Electro Medical Systems. The 510(k) number is K991874.

When did EMS SURFACE MOUNT SCALER receive FDA 510(k) clearance?

EMS SURFACE MOUNT SCALER received FDA 510(k) clearance on 1999-07-30, under 510(k) number K991874.

Who is the listed applicant for EMS SURFACE MOUNT SCALER?

The FDA 510(k) record lists (Ems Sa) Electro Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMS SURFACE MOUNT SCALER?

The FDA product code for EMS SURFACE MOUNT SCALER is ELC.

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 (Ems Sa) Electro Medical Systems 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.

K073284AIR-FLOW MASTER STANDARDK032099SWISS MASTER LIGHTK992504EMS KERMITK991588EMS SWISS ORTHOCLAST

Related Devices (Code: ELC)

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.

K260773Varios Combi Pro2Nakanishi, Inc.K253254GBT Machine Airflow Prophylaxis MasterE.M.S Electro Medical Systems S.AK251689VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)Nakanishi, Inc.K242317Integrated Endo System (Meet Endo-II)Denjoy Dental Co., Ltd.K233844OdneCleanOdne AGK240707Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-JY-M0014, WD-JY-N0015,WD-JY-N0016,WD-JY-N0017,WD-JY-E007, WD-JY-F008,WD-JY-A005,WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0014,WD-JY-L0015, WD-JY-L0016,WD-JY-L0017)Shenzhen Micro Electric Intelligence Co., Ltd.

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.

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