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FDA 510(k)

COPAL DIGITAL SPHYGMOMANOMETER UA-535

K-Number: K843390 · 1985-05-15

ApplicantTakeda Medical, Inc.
Decision Date1985-05-15
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COPAL DIGITAL SPHYGMOMANOMETER UA-535 is the device name listed in this FDA 510(k) record. The listed applicant is Takeda Medical, Inc.. It received FDA 510(k) clearance on 1985-05-15 under 510(k) number K843390. 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 COPAL DIGITAL SPHYGMOMANOMETER UA-535?

COPAL DIGITAL SPHYGMOMANOMETER UA-535 is a medical device that received FDA 510(k) clearance on 1985-05-15. The listed applicant is Takeda Medical, Inc.. The 510(k) number is K843390.

When did COPAL DIGITAL SPHYGMOMANOMETER UA-535 receive FDA 510(k) clearance?

COPAL DIGITAL SPHYGMOMANOMETER UA-535 received FDA 510(k) clearance on 1985-05-15, under 510(k) number K843390.

Who is the listed applicant for COPAL DIGITAL SPHYGMOMANOMETER UA-535?

The FDA 510(k) record lists Takeda Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COPAL DIGITAL SPHYGMOMANOMETER UA-535?

The FDA product code for COPAL DIGITAL SPHYGMOMANOMETER UA-535 is DXN.

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Other records listing Takeda Medical, Inc. 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.

K854797TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER, UA-731K853158DIGITAL SPHYGMOMANOMETER MODEL 7620K851223COPAL DIGITAL SPHYGMOMANOMETER UA-560K852564COPAL UA-512 DIGITAL BLOOD PRESSURE MONITORK844285COPAL DIGITAL SPHYGMOMAMOMETER UA-550K842388COPAL DIGITAL SPHYGMOMANOMETER UA-510

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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

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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