Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

COLIN PRESS MATE, MODEL BP S510

K-Number: K063690 · 2007-05-09

ApplicantOmron Healthcare, Inc.
Decision Date2007-05-09
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COLIN PRESS MATE, MODEL BP S510 is the device name listed in this FDA 510(k) record. The listed applicant is Omron Healthcare, Inc.. It received FDA 510(k) clearance on 2007-05-09 under 510(k) number K063690. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLIN PRESS MATE, MODEL BP S510?

COLIN PRESS MATE, MODEL BP S510 is a medical device that received FDA 510(k) clearance on 2007-05-09. The listed applicant is Omron Healthcare, Inc.. The 510(k) number is K063690.

When did COLIN PRESS MATE, MODEL BP S510 receive FDA 510(k) clearance?

COLIN PRESS MATE, MODEL BP S510 received FDA 510(k) clearance on 2007-05-09, under 510(k) number K063690.

Who is the listed applicant for COLIN PRESS MATE, MODEL BP S510?

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

What is the FDA product code for COLIN PRESS MATE, MODEL BP S510?

The FDA product code for COLIN PRESS MATE, MODEL BP S510 is MHX.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Omron Healthcare, 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.

K261929Upper Arm Blood pressure monitor (BP7155D)K202228Omron Model BP7900 Blood Pressure Monitor + EKGK183215Focus TENS Therapy, Model PM710-M/-LK190693HEM-6410T-ZL Wrist Blood Pressure MonitorK182579Omron Model BP7900 Blood Pressure Monitor + EKGK182120Maxpower Relief

View all 63 devices →

Related Devices (Code: MHX)

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.

K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0MGE Healthcare Finland OyK260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland OyK260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.K254209Radius VSM and AccessoriesMasimo Corporation

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.

↑