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FDA 510(k)

AMBULATORY PH RECORDING DEVICE

K-Number: K842349 · 1985-06-14

ApplicantClinical Data Instruments, Inc.
Decision Date1985-06-14
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AMBULATORY PH RECORDING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Data Instruments, Inc.. It received FDA 510(k) clearance on 1985-06-14 under 510(k) number K842349. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMBULATORY PH RECORDING DEVICE?

AMBULATORY PH RECORDING DEVICE is a medical device that received FDA 510(k) clearance on 1985-06-14. The listed applicant is Clinical Data Instruments, Inc.. The 510(k) number is K842349.

When did AMBULATORY PH RECORDING DEVICE receive FDA 510(k) clearance?

AMBULATORY PH RECORDING DEVICE received FDA 510(k) clearance on 1985-06-14, under 510(k) number K842349.

Who is the listed applicant for AMBULATORY PH RECORDING DEVICE?

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

What is the FDA product code for AMBULATORY PH RECORDING DEVICE?

The FDA product code for AMBULATORY PH RECORDING DEVICE is DSH.

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 Clinical Data 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.

K832828CENTURION CARDIAC DETECTORK832829NEO-FLOAT NEONATAL FLOTATION SYS & RHYT

Related Devices (Code: DSH)

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.

K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.K253293VitaloJAK Clinic (Model 7100)Vitalograph , Ltd.K243650Zio® monitor (DFG0001)iRhythm Technologies, Inc.K243603AeviceMDAevice Health Pte. , Ltd.K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.

Official Source

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