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)

Getinge Assured MI Steam Migrating Integrator

K-Number: K242795 · 2024-10-15

ApplicantSteritec Products Mfg. (A Getinge Group Company)
Decision Date2024-10-15
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Getinge Assured MI Steam Migrating Integrator is the device name listed in this FDA 510(k) record. The listed applicant is Steritec Products Mfg. (A Getinge Group Company). It received FDA 510(k) clearance on 2024-10-15 under 510(k) number K242795. 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 Getinge Assured MI Steam Migrating Integrator?

Getinge Assured MI Steam Migrating Integrator is a medical device that received FDA 510(k) clearance on 2024-10-15. The listed applicant is Steritec Products Mfg. (A Getinge Group Company). The 510(k) number is K242795.

When did Getinge Assured MI Steam Migrating Integrator receive FDA 510(k) clearance?

Getinge Assured MI Steam Migrating Integrator received FDA 510(k) clearance on 2024-10-15, under 510(k) number K242795.

Who is the listed applicant for Getinge Assured MI Steam Migrating Integrator?

The FDA 510(k) record lists Steritec Products Mfg. (A Getinge Group Company) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Getinge Assured MI Steam Migrating Integrator?

The FDA product code for Getinge Assured MI Steam Migrating Integrator is JOJ.

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.

K260181LF 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 CorporationK250172Green Card Bowie-Dick Test (BD115)Steritec Products, Inc. (A Getinge Company)

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.

↑