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FDA 510(k)

SYSTEM 7100 NON-INVASIVE BLOOD PRESSURE MONITOR

K-Number: K897173 · 1990-10-23

ApplicantAdvanced Medical Instruments, Inc.
Decision Date1990-10-23
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SYSTEM 7100 NON-INVASIVE BLOOD PRESSURE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Medical Instruments, Inc.. It received FDA 510(k) clearance on 1990-10-23 under 510(k) number K897173. 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 SYSTEM 7100 NON-INVASIVE BLOOD PRESSURE MONITOR?

SYSTEM 7100 NON-INVASIVE BLOOD PRESSURE MONITOR is a medical device that received FDA 510(k) clearance on 1990-10-23. The listed applicant is Advanced Medical Instruments, Inc.. The 510(k) number is K897173.

When did SYSTEM 7100 NON-INVASIVE BLOOD PRESSURE MONITOR receive FDA 510(k) clearance?

SYSTEM 7100 NON-INVASIVE BLOOD PRESSURE MONITOR received FDA 510(k) clearance on 1990-10-23, under 510(k) number K897173.

Who is the listed applicant for SYSTEM 7100 NON-INVASIVE BLOOD PRESSURE MONITOR?

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

What is the FDA product code for SYSTEM 7100 NON-INVASIVE BLOOD PRESSURE MONITOR?

The FDA product code for SYSTEM 7100 NON-INVASIVE BLOOD PRESSURE MONITOR 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 Advanced Medical Instruments, 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.

K923595SYSTEM 7110 NON-INVASIVE BLOOD PRESSURE MONITORK924910SYSTEM 7500 NIBP/SA02K910521SYSTEM 7300 PULSE OXIMETERK896788DISP. NEONATAL BLOOD PRESSURE MONITORING CUFF

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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