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FDA 510(k)

PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENT

K-Number: K912428 · 1991-08-09

ApplicantPuritan Bennett Corp.
Decision Date1991-08-09
Product CodeCBZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENT 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 1991-08-09 under 510(k) number K912428. The device is classified under product code CBZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENT?

PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENT is a medical device that received FDA 510(k) clearance on 1991-08-09. The listed applicant is Puritan Bennett Corp.. The 510(k) number is K912428.

When did PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENT receive FDA 510(k) clearance?

PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENT received FDA 510(k) clearance on 1991-08-09, under 510(k) number K912428.

Who is the listed applicant for PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENT?

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 PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENT?

The FDA product code for PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENT is CBZ.

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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: CBZ)

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.

K020967TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEMTerumo Cardiovascular Systems Corp.K970906PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 PLUS MULTIPARAMETER SENSORDiametrics Medical, Ltd.K931112MODEL PB3300 INTRA-ARTER BLOOD GAS MONIT SYS, MODIPuritan Bennett Corp.K920061HEMOMETRIX CONTINUOUS BLOOD GAS MONITORING SYSTEMAbbott LaboratoriesK912030CDI(TM) 2000 BLOOD GAS MONITORING SYST, MODIFIED3M CompanyK884228CDI(R) 2000 BLOOD GAS MONITORCardiovascular Devices, 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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