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)

BIOLOGIC DT-1000 MACHINE

K-Number: K923046 · 1994-09-30

ApplicantHemocleanse, Inc.
Decision Date1994-09-30
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BIOLOGIC DT-1000 MACHINE is the device name listed in this FDA 510(k) record. The listed applicant is Hemocleanse, Inc.. It received FDA 510(k) clearance on 1994-09-30 under 510(k) number K923046. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOLOGIC DT-1000 MACHINE?

BIOLOGIC DT-1000 MACHINE is a medical device that received FDA 510(k) clearance on 1994-09-30. The listed applicant is Hemocleanse, Inc.. The 510(k) number is K923046.

When did BIOLOGIC DT-1000 MACHINE receive FDA 510(k) clearance?

BIOLOGIC DT-1000 MACHINE received FDA 510(k) clearance on 1994-09-30, under 510(k) number K923046.

Who is the listed applicant for BIOLOGIC DT-1000 MACHINE?

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

What is the FDA product code for BIOLOGIC DT-1000 MACHINE?

The FDA product code for BIOLOGIC DT-1000 MACHINE is KNT.

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 Hemocleanse, 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.

K993330THERMOCHEM-HT SYSTEMK992196BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK)K984546BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TKK953751BIOLOGIC-DT SYSTEM

Related Devices (Code: KNT)

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.

K26189052Fr ViSiGi LUX™; 52Fr ViSiGi 3D®Boehringer Laboratories, LLCK253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)C.R. Bard, Inc.K250389XNY Disposable Gastric Calibration TubeChangzhou Xin Neng Yuan Medical Stapler Co.,LtdK243228Flexi-Seal AIR (with ENFit Connector)ConvatecK242336hygh-tec Drainage IIAmb MedtecK242901ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)Tools For Surgery, LLC

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.

↑