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FDA 510(k)

D668 & D664 CENTRAL MONITORING SYSTEMS

K-Number: K800243 · 1980-04-10

ApplicantMedtel Pty. , Ltd.
Decision Date1980-04-10
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

D668 & D664 CENTRAL MONITORING SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Medtel Pty. , Ltd.. It received FDA 510(k) clearance on 1980-04-10 under 510(k) number K800243. 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 D668 & D664 CENTRAL MONITORING SYSTEMS?

D668 & D664 CENTRAL MONITORING SYSTEMS is a medical device that received FDA 510(k) clearance on 1980-04-10. The listed applicant is Medtel Pty. , Ltd.. The 510(k) number is K800243.

When did D668 & D664 CENTRAL MONITORING SYSTEMS receive FDA 510(k) clearance?

D668 & D664 CENTRAL MONITORING SYSTEMS received FDA 510(k) clearance on 1980-04-10, under 510(k) number K800243.

Who is the listed applicant for D668 & D664 CENTRAL MONITORING SYSTEMS?

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

What is the FDA product code for D668 & D664 CENTRAL MONITORING SYSTEMS?

The FDA product code for D668 & D664 CENTRAL MONITORING SYSTEMS is DRT.

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Other records listing Medtel Pty. , Ltd. 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.

K832356PORTABLE OPERAT. RM. MONITORS HS30/40K820670HS17/HS18 SERIES MONITORSK820671CM10 CENTRAL MONITORING SYSTEMK820399HS20 PORT. OPERATING ROOM MONITORK802184HS10 PORTABLE OPERATING ROOM MONITORK791839H59 CRITICAL CARE MONITOR

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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

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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