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FDA 510(k)

BEDSIDE PATIENT MONITOR W/MODULES

K-Number: K850619 · 1985-06-06

ApplicantMidwest Analog & Digital, Inc.
Decision Date1985-06-06
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BEDSIDE PATIENT MONITOR W/MODULES is the device name listed in this FDA 510(k) record. The listed applicant is Midwest Analog & Digital, Inc.. It received FDA 510(k) clearance on 1985-06-06 under 510(k) number K850619. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BEDSIDE PATIENT MONITOR W/MODULES?

BEDSIDE PATIENT MONITOR W/MODULES is a medical device that received FDA 510(k) clearance on 1985-06-06. The listed applicant is Midwest Analog & Digital, Inc.. The 510(k) number is K850619.

When did BEDSIDE PATIENT MONITOR W/MODULES receive FDA 510(k) clearance?

BEDSIDE PATIENT MONITOR W/MODULES received FDA 510(k) clearance on 1985-06-06, under 510(k) number K850619.

Who is the listed applicant for BEDSIDE PATIENT MONITOR W/MODULES?

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

What is the FDA product code for BEDSIDE PATIENT MONITOR W/MODULES?

The FDA product code for BEDSIDE PATIENT MONITOR W/MODULES is DRT.

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 Midwest Analog & Digital, 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.

K781873RECORDER, STRIP CHART WITH PRINTERK780432ARRHYTHMIA PROGRAM MODULE

Related Devices (Code: DRT)

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.

K254058DistaSense(TM) (v1)Life Detection TechnologiesK261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AGK251364Sleepiz One+ (2.5)Sleepiz AGK234003The Circadia C200 SystemCircadia Technologies, Ltd.

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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