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FDA 510(k)

EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One

K-Number: K190124 · 2019-10-20

ApplicantE.M.S Electro Medical Systems S.A
Decision Date2019-10-20
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One is the device name listed in this FDA 510(k) record. The listed applicant is E.M.S Electro Medical Systems S.A. It received FDA 510(k) clearance on 2019-10-20 under 510(k) number K190124. 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 AIRFLOW Prophylaxis Master, EMS AIRFLOW One?

EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One is a medical device that received FDA 510(k) clearance on 2019-10-20. The listed applicant is E.M.S Electro Medical Systems S.A. The 510(k) number is K190124.

When did EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One receive FDA 510(k) clearance?

EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One received FDA 510(k) clearance on 2019-10-20, under 510(k) number K190124.

Who is the listed applicant for EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One?

The FDA 510(k) record lists E.M.S Electro Medical Systems S.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One?

The FDA product code for EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One is ELC.

Other records listing E.M.S Electro Medical Systems S.A as applicant

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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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