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FDA 510(k)

PIEZON MASTER 400

K-Number: K896749 · 1990-08-31

ApplicantElectro Medical Systems (Ems Sa)
Decision Date1990-08-31
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PIEZON MASTER 400 is the device name listed in this FDA 510(k) record. The listed applicant is Electro Medical Systems (Ems Sa). It received FDA 510(k) clearance on 1990-08-31 under 510(k) number K896749. 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 PIEZON MASTER 400?

PIEZON MASTER 400 is a medical device that received FDA 510(k) clearance on 1990-08-31. The listed applicant is Electro Medical Systems (Ems Sa). The 510(k) number is K896749.

When did PIEZON MASTER 400 receive FDA 510(k) clearance?

PIEZON MASTER 400 received FDA 510(k) clearance on 1990-08-31, under 510(k) number K896749.

Who is the listed applicant for PIEZON MASTER 400?

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

What is the FDA product code for PIEZON MASTER 400?

The FDA product code for PIEZON MASTER 400 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 Electro Medical Systems (Ems Sa) 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.

K900709AIR FLOW SII

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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