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FDA 510(k)

MAGTARAK RESPIRATORY MONITOR & FLOW SENS

K-Number: K823555 · 1983-01-05

ApplicantPenlon, Inc.
Decision Date1983-01-05
Product CodeBZK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MAGTARAK RESPIRATORY MONITOR & FLOW SENS is the device name listed in this FDA 510(k) record. The listed applicant is Penlon, Inc.. It received FDA 510(k) clearance on 1983-01-05 under 510(k) number K823555. The device is classified under product code BZK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAGTARAK RESPIRATORY MONITOR & FLOW SENS?

MAGTARAK RESPIRATORY MONITOR & FLOW SENS is a medical device that received FDA 510(k) clearance on 1983-01-05. The listed applicant is Penlon, Inc.. The 510(k) number is K823555.

When did MAGTARAK RESPIRATORY MONITOR & FLOW SENS receive FDA 510(k) clearance?

MAGTARAK RESPIRATORY MONITOR & FLOW SENS received FDA 510(k) clearance on 1983-01-05, under 510(k) number K823555.

Who is the listed applicant for MAGTARAK RESPIRATORY MONITOR & FLOW SENS?

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

What is the FDA product code for MAGTARAK RESPIRATORY MONITOR & FLOW SENS?

The FDA product code for MAGTARAK RESPIRATORY MONITOR & FLOW SENS is BZK.

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Other records listing Penlon, Inc. 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.

K936046SIGMA ELITEK902381PENLON BREATHING SYSTEM PRESSURE MONITORK894689PENLON IDP PRESSURE FAILURE ALARMK844008PENLON AM1000 ANAESTHESIA MACHINEK844007PENLON PPV VAPORIZERK803052NUFFIELD ANESTHESIA VENTILATOR SER. 400

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Related Devices (Code: BZK)

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.

K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.K192584BEACON Caresystem Model 00002144Mermaid Care A/SK192595ExSpiron 2XiRespiratory MotionK180788Gas Module 3Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K173181ExSpiron 1XiRespiratory Motion, Inc.K162131ExSpiron 1XiRespiratory Motion, 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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