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FDA 510(k)

BPCARD

K-Number: K031964 · 2003-09-05

ApplicantQrs Diagnostic, LLC
Decision Date2003-09-05
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BPCARD is the device name listed in this FDA 510(k) record. The listed applicant is Qrs Diagnostic, LLC. It received FDA 510(k) clearance on 2003-09-05 under 510(k) number K031964. 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 BPCARD?

BPCARD is a medical device that received FDA 510(k) clearance on 2003-09-05. The listed applicant is Qrs Diagnostic, LLC. The 510(k) number is K031964.

When did BPCARD receive FDA 510(k) clearance?

BPCARD received FDA 510(k) clearance on 2003-09-05, under 510(k) number K031964.

Who is the listed applicant for BPCARD?

The FDA 510(k) record lists Qrs Diagnostic, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BPCARD?

The FDA product code for BPCARD is DXN.

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Other records listing Qrs Diagnostic, LLC 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.

K083749CARDIOVIEW32 REVIEW MODULEK073630MODIFICATION TO: BPCARD, MODEL Z-7000-0700K030535EKGCARD SYSTEMK001278SENSAIRE DIAGNOSTIC SPIROMETERK001995SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETERK973138SPIROCARD

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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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