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FDA 510(k)

SYSTEM I INFANT MONITORING SYS

K-Number: K820943 · 1982-05-03

ApplicantBurr Engineering & Development Co.
Decision Date1982-05-03
Product CodeFLS
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SYSTEM I INFANT MONITORING SYS is the device name listed in this FDA 510(k) record. The listed applicant is Burr Engineering & Development Co.. It received FDA 510(k) clearance on 1982-05-03 under 510(k) number K820943. 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 SYSTEM I INFANT MONITORING SYS?

SYSTEM I INFANT MONITORING SYS is a medical device that received FDA 510(k) clearance on 1982-05-03. The listed applicant is Burr Engineering & Development Co.. The 510(k) number is K820943.

When did SYSTEM I INFANT MONITORING SYS receive FDA 510(k) clearance?

SYSTEM I INFANT MONITORING SYS received FDA 510(k) clearance on 1982-05-03, under 510(k) number K820943.

Who is the listed applicant for SYSTEM I INFANT MONITORING SYS?

The FDA 510(k) record lists Burr Engineering & Development Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYSTEM I INFANT MONITORING SYS?

The FDA product code for SYSTEM I INFANT MONITORING SYS is FLS.

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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

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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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