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)

CASTLE TEC-TEST AERATION MONITOR

K-Number: K761011 · 1976-12-02

ApplicantCastle Co.
Decision Date1976-12-02
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CASTLE TEC-TEST AERATION MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Castle Co.. It received FDA 510(k) clearance on 1976-12-02 under 510(k) number K761011. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CASTLE TEC-TEST AERATION MONITOR?

CASTLE TEC-TEST AERATION MONITOR is a medical device that received FDA 510(k) clearance on 1976-12-02. The listed applicant is Castle Co.. The 510(k) number is K761011.

When did CASTLE TEC-TEST AERATION MONITOR receive FDA 510(k) clearance?

CASTLE TEC-TEST AERATION MONITOR received FDA 510(k) clearance on 1976-12-02, under 510(k) number K761011.

Who is the listed applicant for CASTLE TEC-TEST AERATION MONITOR?

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

What is the FDA product code for CASTLE TEC-TEST AERATION MONITOR?

The FDA product code for CASTLE TEC-TEST AERATION MONITOR is JOJ.

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 Castle Co. 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.

K870975MODIFIED CASTLE POWERCLAVEK860263CASTLE 7538 FLOOR LOADING WASHERK844089CASTLE 7515 UTENSIL/GLASSWARE WASHERK834048BOVIE CONDUCTIVE ADHES-DISPER-ELECTROK833074CASTLE TEC-TEST S.M.A.R.T. PACKK831595CASTLE MODEL 3341 & 3441 & 4141 GAS AER

View all 21 devices →

Related Devices (Code: JOJ)

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.

K2619923M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)Solventum US, LLCK260181LF Process Indicator Tape for Steam SterilizationIntertape Polymer GroupK251991SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.K251035DISINTEK™ PA Test StripsSerim ResearchK251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118STERIS CorporationK243876VERIFY STEAM Integrating IndicatorSTERIS Corporation

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.

↑