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FDA 510(k)

DIGITAL SPHYGMOMANOMETER

K-Number: K871371 · 1987-06-12

ApplicantOmron Tateisi Electronics Co.
Decision Date1987-06-12
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DIGITAL SPHYGMOMANOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Omron Tateisi Electronics Co.. It received FDA 510(k) clearance on 1987-06-12 under 510(k) number K871371. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGITAL SPHYGMOMANOMETER?

DIGITAL SPHYGMOMANOMETER is a medical device that received FDA 510(k) clearance on 1987-06-12. The listed applicant is Omron Tateisi Electronics Co.. The 510(k) number is K871371.

When did DIGITAL SPHYGMOMANOMETER receive FDA 510(k) clearance?

DIGITAL SPHYGMOMANOMETER received FDA 510(k) clearance on 1987-06-12, under 510(k) number K871371.

Who is the listed applicant for DIGITAL SPHYGMOMANOMETER?

The FDA 510(k) record lists Omron Tateisi Electronics Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIGITAL SPHYGMOMANOMETER?

The FDA product code for DIGITAL SPHYGMOMANOMETER is DRS.

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Other records listing Omron Tateisi Electronics Co. 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.

K881601OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM403CK881602OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM703CK864466OMRON ULTRASONIC NEBULIZER MODEL NE-UO5K854201OMRON DIGITAL BP MONITOR HEM-700CPK853260OMRON DIGITAL BP MONITOR HEM-700CK851707OMRON DIGITAL BP MONITOR HEM-400C

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Related Devices (Code: DRS)

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.

K254074TruPressProcerus EnterprisesK242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLCK221782Meritrans ECO Reusable Pressure Transducer, Meritrans ECO DomesMerit Medical Pte. , Ltd.K172458HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer KitSmiths Medical Asd, Inc.K163172HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer KitSmiths Medical Asd, Inc.K161408Compass Cast and MAPCenturion Medical Products 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.

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