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FDA 510(k)

BIG BEN

K-Number: K942650 · 1994-08-15

ApplicantRud Riester GmbH & CO KG
Decision Date1994-08-15
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIG BEN is the device name listed in this FDA 510(k) record. The listed applicant is Rud Riester GmbH & CO KG. It received FDA 510(k) clearance on 1994-08-15 under 510(k) number K942650. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIG BEN?

BIG BEN is a medical device that received FDA 510(k) clearance on 1994-08-15. The listed applicant is Rud Riester GmbH & CO KG. The 510(k) number is K942650.

When did BIG BEN receive FDA 510(k) clearance?

BIG BEN received FDA 510(k) clearance on 1994-08-15, under 510(k) number K942650.

Who is the listed applicant for BIG BEN?

The FDA 510(k) record lists Rud Riester GmbH & CO KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIG BEN?

The FDA product code for BIG BEN is DXN.

Other records listing Rud Riester GmbH & CO KG 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.

K944337VARIOUS STETHOSCOPESK942649MINIMUS I; MINIMUS III, SANAPHONK943461VARIOUS TYPES OF MERCURIALS

Related Devices (Code: DXN)

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.

K261929Upper Arm Blood pressure monitor (BP7155D)OMRON Healthcare, Inc.K254000Happy Health Blood Pressure MonitorHappy Health, Inc.K262658Automatic Digital Blood Pressure monitor (LD-526)Honsun (Nantong) Co., Ltd.K261394Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)JOYTECH Healthcare Co., Ltd.K253425Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)Joytech Healthcare Co. , Ltd.K261061BP Go (BPP-855)Wellvii, Inc.

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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