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FDA 510(k)

VANTAGE ABI

K-Number: K103693 · 2011-02-15

ApplicantSummit Doppler Systems, Inc.
Decision Date2011-02-15
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VANTAGE ABI is the device name listed in this FDA 510(k) record. The listed applicant is Summit Doppler Systems, Inc.. It received FDA 510(k) clearance on 2011-02-15 under 510(k) number K103693. 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 VANTAGE ABI?

VANTAGE ABI is a medical device that received FDA 510(k) clearance on 2011-02-15. The listed applicant is Summit Doppler Systems, Inc.. The 510(k) number is K103693.

When did VANTAGE ABI receive FDA 510(k) clearance?

VANTAGE ABI received FDA 510(k) clearance on 2011-02-15, under 510(k) number K103693.

Who is the listed applicant for VANTAGE ABI?

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

What is the FDA product code for VANTAGE ABI?

The FDA product code for VANTAGE ABI is DXN.

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Other records listing Summit Doppler Systems, 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.

K101816STN PROBEK093393LIFEDOP MODEL 300ABIK090499LIFEDOP MODEL, L350RK063600VISTA AVSK060410ECHOHEART TRANSVAGINAL DOPPLER PROBEK024197LIFEDOP DOPPLER

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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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