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)

PFM PROFESSIONAL 7000 SPIROMETER

K-Number: K932278 · 1993-12-17

ApplicantAdvanced Medical Systems, Inc.
Decision Date1993-12-17
Product CodeBTY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PFM PROFESSIONAL 7000 SPIROMETER is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Medical Systems, Inc.. It received FDA 510(k) clearance on 1993-12-17 under 510(k) number K932278. The device is classified under product code BTY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PFM PROFESSIONAL 7000 SPIROMETER?

PFM PROFESSIONAL 7000 SPIROMETER is a medical device that received FDA 510(k) clearance on 1993-12-17. The listed applicant is Advanced Medical Systems, Inc.. The 510(k) number is K932278.

When did PFM PROFESSIONAL 7000 SPIROMETER receive FDA 510(k) clearance?

PFM PROFESSIONAL 7000 SPIROMETER received FDA 510(k) clearance on 1993-12-17, under 510(k) number K932278.

Who is the listed applicant for PFM PROFESSIONAL 7000 SPIROMETER?

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

What is the FDA product code for PFM PROFESSIONAL 7000 SPIROMETER?

The FDA product code for PFM PROFESSIONAL 7000 SPIROMETER is BTY.

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 Advanced Medical Systems, 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.

K955931MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION)K952031ULTRASOUND TRANSDUCER, MODEL US917K940898MODEL IM77 INTRAPARTUM FETAL MONITORK923335ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATIONK911657FETAL SCALP SPIRAL ELECTRODEK902190FETAL PULSE DETECTOR MODEL DOP-1

View all 10 devices →

Related Devices (Code: BTY)

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.

K260242CPETWise PlatformMedibyt , Ltd.K242809Ascent Cardiorespiratory Diagnostic SoftwareMedical Graphics CorporationK223629SpiroSphere, SpiroSphereECG, CardioSphereEresearchtechnology GmbHK231561Pulmonary Function Tester, Model: A9Guangzhou Homesun Medical Technology Co., Ltd.K222982Virtus Metabolic MonitorVirtus Technology ApsK221030Model 9100 PFT/DICOVitalograph Ireland, Ltd.

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.

↑