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FDA 510(k)

FOCUS

K-Number: K001729 · 2000-07-13

ApplicantInstrumentarium Corp.
Decision Date2000-07-13
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FOCUS is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentarium Corp.. It received FDA 510(k) clearance on 2000-07-13 under 510(k) number K001729. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOCUS?

FOCUS is a medical device that received FDA 510(k) clearance on 2000-07-13. The listed applicant is Instrumentarium Corp.. The 510(k) number is K001729.

When did FOCUS receive FDA 510(k) clearance?

FOCUS received FDA 510(k) clearance on 2000-07-13, under 510(k) number K001729.

Who is the listed applicant for FOCUS?

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

What is the FDA product code for FOCUS?

The FDA product code for FOCUS is EHD.

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Related PubMed Literature

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Other records listing Instrumentarium Corp. 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.

K022630MODIFICATION TO FOCUSK001439ORTHOCEPH OC100 DK992385ORTHOPANTOMOGRAPH OP100DK981641MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQK962638TONOCAP, TC-200 AND ACCESSORY CATHETERSK961441TONOMETERED SLAINE BLOOD GAS CONTROL

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Related Devices (Code: EHD)

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.

K260795Hand-held Dental X-ray System (HyperLight-M)Changzhou Sifary Medical Technology Co., Ltd.K260367Portable Dental X-ray System Model PDX novaPDX Co., Ltd.K253864NOMAD Pro 3Dental Imaging Technologies CorporationK252110Dental X-RAY Unit (AJX200)Guangzhou Ajax Medical Equipment Co., Ltd.K254018Portable Dental X-ray Device (GT-1)Guilin Refine Medical Instrument Co., Ltd.K252909Diagnostic X-Ray Equipment Model POCT22Ningbo Runyes Medical Instrument Co., Ltd.

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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