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FDA 510(k)

BIOSPACE

K-Number: K131064 · 2013-09-04

ApplicantBiospace Corporation Limited
Decision Date2013-09-04
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOSPACE is the device name listed in this FDA 510(k) record. The listed applicant is Biospace Corporation Limited. It received FDA 510(k) clearance on 2013-09-04 under 510(k) number K131064. 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 BIOSPACE?

BIOSPACE is a medical device that received FDA 510(k) clearance on 2013-09-04. The listed applicant is Biospace Corporation Limited. The 510(k) number is K131064.

When did BIOSPACE receive FDA 510(k) clearance?

BIOSPACE received FDA 510(k) clearance on 2013-09-04, under 510(k) number K131064.

Who is the listed applicant for BIOSPACE?

The FDA 510(k) record lists Biospace Corporation Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOSPACE?

The FDA product code for BIOSPACE is DXN.

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Other records listing Biospace Corporation Limited 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.

K130777INBODYK123228INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B)K110689INBODYK092786INBODY, MODELS: 270, R20, R20BK062603BIOSPACE BODY COMPOSITION ANALYZERS, MODEL INBODY 230K052646BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 AND S20

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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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