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FDA 510(k)

413A NEONATAL MONITOR

K-Number: K800164 · 1980-04-10

ApplicantXerox Corp.
Decision Date1980-04-10
Product CodeFLS
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

413A NEONATAL MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Xerox Corp.. It received FDA 510(k) clearance on 1980-04-10 under 510(k) number K800164. The device is classified under product code FLS. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 413A NEONATAL MONITOR?

413A NEONATAL MONITOR is a medical device that received FDA 510(k) clearance on 1980-04-10. The listed applicant is Xerox Corp.. The 510(k) number is K800164.

When did 413A NEONATAL MONITOR receive FDA 510(k) clearance?

413A NEONATAL MONITOR received FDA 510(k) clearance on 1980-04-10, under 510(k) number K800164.

Who is the listed applicant for 413A NEONATAL MONITOR?

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

What is the FDA product code for 413A NEONATAL MONITOR?

The FDA product code for 413A NEONATAL MONITOR is FLS.

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 Xerox Corp. 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.

K837513UNKNOWN

Related Devices (Code: FLS)

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.

K011597SMARTMONITOR 2, MODEL 4000Respironics Georgia, Inc.K991087HANNAH WIRELESS VITAL SIGNS MONITORIlife Systems, Inc.K962865REMBRANDT SYSTEMAirsep Corp.K951246PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONSProtocol Systems, Inc.K894973RESPITRACE PLUSHogan & HartsonK832999RESPIRATION MONITORLitton Medical Electronics

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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