Decision Date1979-11-27
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
MW-8000 is the device name listed in this FDA 510(k) record. The listed applicant is Midwest. It received FDA 510(k) clearance on 1979-11-27 under 510(k) number K792304. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MW-8000?
MW-8000 is a medical device that received FDA 510(k) clearance on 1979-11-27. The listed applicant is Midwest. The 510(k) number is K792304.
When did MW-8000 receive FDA 510(k) clearance?
MW-8000 received FDA 510(k) clearance on 1979-11-27, under 510(k) number K792304.
Who is the listed applicant for MW-8000?
The FDA 510(k) record lists Midwest as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MW-8000?
The FDA product code for MW-8000 is EFB.
Other records listing Midwest 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.
View all 13 devices →
Related Devices (Code: EFB)
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.
K262144DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd.K251388Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)Foshan Topmed Dental Co., Ltd.K251389High speed air turbine handpieceFoshan Topmed Dental Co., Ltd.K242179Synea Fusion Handpieces (Intensiv & Profin)W&H Dentalwerk Bürmoos GmbHK240337Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)Guangdong Jinme Medical Technology Co., Ltd.K241074High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)Foshan Soco Precision Instrument 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.