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FDA 510(k)

ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80

K-Number: K032954 · 2004-08-09

ApplicantDanmeter A/S
Decision Date2004-08-09
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80 is the device name listed in this FDA 510(k) record. The listed applicant is Danmeter A/S. It received FDA 510(k) clearance on 2004-08-09 under 510(k) number K032954. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80?

ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80 is a medical device that received FDA 510(k) clearance on 2004-08-09. The listed applicant is Danmeter A/S. The 510(k) number is K032954.

When did ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80 receive FDA 510(k) clearance?

ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80 received FDA 510(k) clearance on 2004-08-09, under 510(k) number K032954.

Who is the listed applicant for ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80?

The FDA 510(k) record lists Danmeter A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80?

The FDA product code for ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80 is IPF.

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.

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Other records listing Danmeter A/S 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.

K042315CEREBRAL STATE MONITOR - CSMK032955AUTOMOVE, MODEL AM800K032988ELPHA 4 CONTI

Related Devices (Code: IPF)

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.

K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali NezakatiK260142StimelMD (SSMD) systemMotion Informatics ltd.K251083Compact IIEnraf-Nonius, B.V.K241433EVE Synergy (EVE-20M)Weero Co., Ltd.K241488TrainFES AdvanceTrainfes

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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