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FDA 510(k)

HS10 PORTABLE OPERATING ROOM MONITOR

K-Number: K802184 · 1980-09-26

ApplicantMedtel Pty. , Ltd.
Decision Date1980-09-26
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HS10 PORTABLE OPERATING ROOM MONITOR 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 1980-09-26 under 510(k) number K802184. 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 HS10 PORTABLE OPERATING ROOM MONITOR?

HS10 PORTABLE OPERATING ROOM MONITOR is a medical device that received FDA 510(k) clearance on 1980-09-26. The listed applicant is Medtel Pty. , Ltd.. The 510(k) number is K802184.

When did HS10 PORTABLE OPERATING ROOM MONITOR receive FDA 510(k) clearance?

HS10 PORTABLE OPERATING ROOM MONITOR received FDA 510(k) clearance on 1980-09-26, under 510(k) number K802184.

Who is the listed applicant for HS10 PORTABLE OPERATING ROOM MONITOR?

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 HS10 PORTABLE OPERATING ROOM MONITOR?

The FDA product code for HS10 PORTABLE OPERATING ROOM MONITOR 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 MONITORK800243D668 & D664 CENTRAL MONITORING SYSTEMSK791839H59 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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