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)

LOWTEM Crystal 120

K-Number: K231893 · 2024-09-18

ApplicantLowtem Co., Ltd.
Decision Date2024-09-18
Product CodeMLR
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LOWTEM Crystal 120 is the device name listed in this FDA 510(k) record. The listed applicant is Lowtem Co., Ltd.. It received FDA 510(k) clearance on 2024-09-18 under 510(k) number K231893. The device is classified under product code MLR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LOWTEM Crystal 120?

LOWTEM Crystal 120 is a medical device that received FDA 510(k) clearance on 2024-09-18. The listed applicant is Lowtem Co., Ltd.. The 510(k) number is K231893.

When did LOWTEM Crystal 120 receive FDA 510(k) clearance?

LOWTEM Crystal 120 received FDA 510(k) clearance on 2024-09-18, under 510(k) number K231893.

Who is the listed applicant for LOWTEM Crystal 120?

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

What is the FDA product code for LOWTEM Crystal 120?

The FDA product code for LOWTEM Crystal 120 is MLR.

Related Devices (Code: MLR)

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.

K252843STERRAD 100NX Sterilization System with ALLClear Technology (10104)Advanced Sterilization Products, Inc.K250802STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)Advanced Sterilization Products, Inc.K234082STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077)Advanced Sterilization ProductsK233762SteroScope® Sterilization Technology SystemIdeate Medical, Inc.K233065V-PRO maX 2 Low Temperature Sterilization SystemSterisK223476V-PRO maX 2 Low Temperature Sterilization SystemSTERIS 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.

↑