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)

SPIROTECH 300

K-Number: K823771 · 1983-01-28

ApplicantSpirotech, Inc.
Decision Date1983-01-28
Product CodeBTY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPIROTECH 300 is the device name listed in this FDA 510(k) record. The listed applicant is Spirotech, Inc.. It received FDA 510(k) clearance on 1983-01-28 under 510(k) number K823771. 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 SPIROTECH 300?

SPIROTECH 300 is a medical device that received FDA 510(k) clearance on 1983-01-28. The listed applicant is Spirotech, Inc.. The 510(k) number is K823771.

When did SPIROTECH 300 receive FDA 510(k) clearance?

SPIROTECH 300 received FDA 510(k) clearance on 1983-01-28, under 510(k) number K823771.

Who is the listed applicant for SPIROTECH 300?

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

What is the FDA product code for SPIROTECH 300?

The FDA product code for SPIROTECH 300 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 Spirotech, 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.

K840972SPIROTECH ST-550K823770SPIROTECH ST-5500

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.

↑