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FDA 510(k)

CARDIOCAP II(TM)

K-Number: K912530 · 1991-09-05

ApplicantDatex Medical Instrumentation, Inc.
Decision Date1991-09-05
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOCAP II(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Datex Medical Instrumentation, Inc.. It received FDA 510(k) clearance on 1991-09-05 under 510(k) number K912530. 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 CARDIOCAP II(TM)?

CARDIOCAP II(TM) is a medical device that received FDA 510(k) clearance on 1991-09-05. The listed applicant is Datex Medical Instrumentation, Inc.. The 510(k) number is K912530.

When did CARDIOCAP II(TM) receive FDA 510(k) clearance?

CARDIOCAP II(TM) received FDA 510(k) clearance on 1991-09-05, under 510(k) number K912530.

Who is the listed applicant for CARDIOCAP II(TM)?

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

What is the FDA product code for CARDIOCAP II(TM)?

The FDA product code for CARDIOCAP II(TM) is DXN.

Related Clinical Trials

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.

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Other records listing Datex Medical Instrumentation, 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.

K955026AS/3 NMT MODULEK961063AS/3 CARDIAC OUTPUT & SVO2 MODULEK960490AS/3 COMPACT AIRWAY MODULE M-CAIOVK953006AS/3 NETWORK LINK

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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