Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PB100 DIAGNOSTIC SPIROMETER

K-Number: K911143 · 1991-11-29

ApplicantPuritan Bennett Corp.
Decision Date1991-11-29
Product CodeBZM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PB100 DIAGNOSTIC SPIROMETER 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 1991-11-29 under 510(k) number K911143. The device is classified under product code BZM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PB100 DIAGNOSTIC SPIROMETER?

PB100 DIAGNOSTIC SPIROMETER is a medical device that received FDA 510(k) clearance on 1991-11-29. The listed applicant is Puritan Bennett Corp.. The 510(k) number is K911143.

When did PB100 DIAGNOSTIC SPIROMETER receive FDA 510(k) clearance?

PB100 DIAGNOSTIC SPIROMETER received FDA 510(k) clearance on 1991-11-29, under 510(k) number K911143.

Who is the listed applicant for PB100 DIAGNOSTIC SPIROMETER?

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 PB100 DIAGNOSTIC SPIROMETER?

The FDA product code for PB100 DIAGNOSTIC SPIROMETER is BZM.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 110 devices →

Related Devices (Code: BZM)

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.

K102229PULMOTRACK 2020 SYSTEMKarmelsonixK090863PERSONAL WHEEZOMETERKarmelsonixK071955WIM-PC, MODEL 1010KarmelsonixK012387STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEMStethographics, Inc.K980878PULMOTRACK,MODEL 1010Karmel Medical Acoustic Technologies , Ltd.K974200ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEMOrca Diagnostics Corp.

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.

↑