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FDA 510(k)

SENSOCOR(TM) DIASYS

K-Number: K881771 · 1989-01-12

ApplicantSensormedix, Inc.
Decision Date1989-01-12
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SENSOCOR(TM) DIASYS is the device name listed in this FDA 510(k) record. The listed applicant is Sensormedix, Inc.. It received FDA 510(k) clearance on 1989-01-12 under 510(k) number K881771. 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 SENSOCOR(TM) DIASYS?

SENSOCOR(TM) DIASYS is a medical device that received FDA 510(k) clearance on 1989-01-12. The listed applicant is Sensormedix, Inc.. The 510(k) number is K881771.

When did SENSOCOR(TM) DIASYS receive FDA 510(k) clearance?

SENSOCOR(TM) DIASYS received FDA 510(k) clearance on 1989-01-12, under 510(k) number K881771.

Who is the listed applicant for SENSOCOR(TM) DIASYS?

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

What is the FDA product code for SENSOCOR(TM) DIASYS?

The FDA product code for SENSOCOR(TM) DIASYS 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.

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 Sensormedix, 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.

K881772SENSOCOR(TM) R-TEST 240 XL

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.

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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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