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FDA 510(k)

PORTABLE OPERAT. RM. MONITORS HS30/40

K-Number: K832356 · 1983-10-28

ApplicantMedtel Pty. , Ltd.
Decision Date1983-10-28
Product CodeBZN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PORTABLE OPERAT. RM. MONITORS HS30/40 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 1983-10-28 under 510(k) number K832356. The device is classified under product code BZN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORTABLE OPERAT. RM. MONITORS HS30/40?

PORTABLE OPERAT. RM. MONITORS HS30/40 is a medical device that received FDA 510(k) clearance on 1983-10-28. The listed applicant is Medtel Pty. , Ltd.. The 510(k) number is K832356.

When did PORTABLE OPERAT. RM. MONITORS HS30/40 receive FDA 510(k) clearance?

PORTABLE OPERAT. RM. MONITORS HS30/40 received FDA 510(k) clearance on 1983-10-28, under 510(k) number K832356.

Who is the listed applicant for PORTABLE OPERAT. RM. MONITORS HS30/40?

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 PORTABLE OPERAT. RM. MONITORS HS30/40?

The FDA product code for PORTABLE OPERAT. RM. MONITORS HS30/40 is BZN.

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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.

K820670HS17/HS18 SERIES MONITORSK820671CM10 CENTRAL MONITORING SYSTEMK820399HS20 PORT. OPERATING ROOM MONITORK802184HS10 PORTABLE OPERATING ROOM MONITORK800243D668 & D664 CENTRAL MONITORING SYSTEMSK791839H59 CRITICAL CARE MONITOR

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Related Devices (Code: BZN)

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.

K924373ACCUFLATE ACCESSORIE CART W/IV POLE AND CLAMPInstrumed, Inc.K872558CART, EMERGENCY, CARDIOPULMONARYNico Metal Products Corp.K850761MODEL PCX/EMY 525A MICROPROCESSSOR CONTROL X-RAY CMedicor USA , Ltd.K840264SERVO CART 170Siemens Elema ABK832697RMP INTUBATION EQUIP. STORAGE TRAYRmp Co.K832355CRASH CARTQuinton, Inc.

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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