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FDA 510(k)

ARTEMA AQUA+ T & TS

K-Number: K912334 · 1991-07-26

ApplicantArtema Medical AB
Decision Date1991-07-26
Product CodeBYD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ARTEMA AQUA+ T & TS is the device name listed in this FDA 510(k) record. The listed applicant is Artema Medical AB. It received FDA 510(k) clearance on 1991-07-26 under 510(k) number K912334. The device is classified under product code BYD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTEMA AQUA+ T & TS?

ARTEMA AQUA+ T & TS is a medical device that received FDA 510(k) clearance on 1991-07-26. The listed applicant is Artema Medical AB. The 510(k) number is K912334.

When did ARTEMA AQUA+ T & TS receive FDA 510(k) clearance?

ARTEMA AQUA+ T & TS received FDA 510(k) clearance on 1991-07-26, under 510(k) number K912334.

Who is the listed applicant for ARTEMA AQUA+ T & TS?

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

What is the FDA product code for ARTEMA AQUA+ T & TS?

The FDA product code for ARTEMA AQUA+ T & TS is BYD.

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 Artema Medical AB 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.

K945359AQUA+I-F, I-H, I-FH, II-H, II-FH, III-HK912335ARTEMA AQUA+ NK912333ARTEMA AQUA+K912336ARTEMA AQUA+ FLEX

Related Devices (Code: BYD)

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.

K955008HEAT & MOISTURE EXCHANGERIntertech Resources, Inc.K954194DISPOSABLE HME/FILTEREngstrom MedicalK953580HEAT MOISTURE EXCHANGERIntertech Resources, Inc.K953507TYPE 1 & 2 (HUMIDAIR I & II)Icor ABK953544HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHTGibeck, Inc.K953620WARM N WET HMEF W/LUER ADAPTERHospitak, Inc.

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.

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