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)

Model 9100 PFT/DICO

K-Number: K221030 · 2022-07-15

ApplicantVitalograph Ireland, Ltd.
Decision Date2022-07-15
Product CodeBTY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Model 9100 PFT/DICO is the device name listed in this FDA 510(k) record. The listed applicant is Vitalograph Ireland, Ltd.. It received FDA 510(k) clearance on 2022-07-15 under 510(k) number K221030. 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 Model 9100 PFT/DICO?

Model 9100 PFT/DICO is a medical device that received FDA 510(k) clearance on 2022-07-15. The listed applicant is Vitalograph Ireland, Ltd.. The 510(k) number is K221030.

When did Model 9100 PFT/DICO receive FDA 510(k) clearance?

Model 9100 PFT/DICO received FDA 510(k) clearance on 2022-07-15, under 510(k) number K221030.

Who is the listed applicant for Model 9100 PFT/DICO?

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

What is the FDA product code for Model 9100 PFT/DICO?

The FDA product code for Model 9100 PFT/DICO is BTY.

Other records listing Vitalograph Ireland, Ltd. 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.

K223818Model 9160 VitaloQUBK212938Vitalograph Model 6000 AlphaK201562SpirotracK200550Vitalograph Model 2120 In2itive eDiaryK160253Vitalograph Model 6300 micro

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.

K242809Ascent Cardiorespiratory Diagnostic SoftwareMedical Graphics CorporationK223629SpiroSphere, SpiroSphereECG, CardioSphereEresearchtechnology GmbHK231561Pulmonary Function Tester, Model: A9Guangzhou Homesun Medical Technology Co., Ltd.K222982Virtus Metabolic MonitorVirtus Technology ApsK202754MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSUEresearchtechnology GmbHK190800Cosmed Q-NRG / Q-NRG+ Portable Metabolic MonitorsCosmed Srl

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.

↑