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FDA 510(k)

ELPHA 4 CONTI

K-Number: K032988 · 2003-12-03

ApplicantDanmeter A/S
Decision Date2003-12-03
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ELPHA 4 CONTI 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 2003-12-03 under 510(k) number K032988. The device is classified under product code KPI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELPHA 4 CONTI?

ELPHA 4 CONTI is a medical device that received FDA 510(k) clearance on 2003-12-03. The listed applicant is Danmeter A/S. The 510(k) number is K032988.

When did ELPHA 4 CONTI receive FDA 510(k) clearance?

ELPHA 4 CONTI received FDA 510(k) clearance on 2003-12-03, under 510(k) number K032988.

Who is the listed applicant for ELPHA 4 CONTI?

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 4 CONTI?

The FDA product code for ELPHA 4 CONTI is KPI.

Related Clinical Trials

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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 - CSMK032954ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80K032955AUTOMOVE, MODEL AM800

Related Devices (Code: KPI)

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.

K262353BTL-299-FBTL Industries, Inc.K260178Pelvic Muscle Trainer (KM510, KM516B)Shenzhen Konmed Technology Co., Ltd.K252601Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L)Hunan Accurate Bio-Medical Technology Co., Ltd.K252552Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)Shenzhen Changkun Technology Co., Ltd.K252831Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)Dolanvy (Suzhou) Medical Technology Co., Ltd.K252334PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)Pontemedag

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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