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FDA 510(k)

PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM

K-Number: K905397 · 1991-05-14

ApplicantPuritan Bennett Corp.
Decision Date1991-05-14
Product CodeCCE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Puritan Bennett Corp.. It received FDA 510(k) clearance on 1991-05-14 under 510(k) number K905397. The device is classified under product code CCE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM?

PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 1991-05-14. The listed applicant is Puritan Bennett Corp.. The 510(k) number is K905397.

When did PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM receive FDA 510(k) clearance?

PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM received FDA 510(k) clearance on 1991-05-14, under 510(k) number K905397.

Who is the listed applicant for PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM?

The FDA 510(k) record lists Puritan Bennett Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM?

The FDA product code for PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM is CCE.

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Other records listing Puritan Bennett Corp. 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.

K063650VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840K053388MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTIONK023225PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWAREK022103PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEMK001646PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTIONK002001BREEZE SLEEPGEAR WITH DREAMSEAL

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Related Devices (Code: CCE)

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.

K935778VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEMVia Medical Corp.K912145SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIAS & W Medico TeknikK910453TOPS NEEDLE TIP PROBE & PVC TIP PROBEBaxter Healthcare CorpK896311OPTEX BLOOD GAS MONITORING SYSTEMOptex BiomedicalK890624TISSUE OXYGEN MONITOR SYSTEM, MODEL IIBaxter Healthcare CorpK895150CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORINGShiley, 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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