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FDA 510(k)

AQUA+I-F, I-H, I-FH, II-H, II-FH, III-H

K-Number: K945359 · 1995-02-21

ApplicantArtema Medical AB
Decision Date1995-02-21
Product CodeBYD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AQUA+I-F, I-H, I-FH, II-H, II-FH, III-H 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 1995-02-21 under 510(k) number K945359. 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 AQUA+I-F, I-H, I-FH, II-H, II-FH, III-H?

AQUA+I-F, I-H, I-FH, II-H, II-FH, III-H is a medical device that received FDA 510(k) clearance on 1995-02-21. The listed applicant is Artema Medical AB. The 510(k) number is K945359.

When did AQUA+I-F, I-H, I-FH, II-H, II-FH, III-H receive FDA 510(k) clearance?

AQUA+I-F, I-H, I-FH, II-H, II-FH, III-H received FDA 510(k) clearance on 1995-02-21, under 510(k) number K945359.

Who is the listed applicant for AQUA+I-F, I-H, I-FH, II-H, II-FH, III-H?

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 AQUA+I-F, I-H, I-FH, II-H, II-FH, III-H?

The FDA product code for AQUA+I-F, I-H, I-FH, II-H, II-FH, III-H is BYD.

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.

K912334ARTEMA AQUA+ T & TSK912335ARTEMA 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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