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FDA 510(k)

VIPERSOFT

K-Number: K984030 · 1999-02-10

ApplicantIntegra Medical
Decision Date1999-02-10
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VIPERSOFT is the device name listed in this FDA 510(k) record. The listed applicant is Integra Medical. It received FDA 510(k) clearance on 1999-02-10 under 510(k) number K984030. 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 VIPERSOFT?

VIPERSOFT is a medical device that received FDA 510(k) clearance on 1999-02-10. The listed applicant is Integra Medical. The 510(k) number is K984030.

When did VIPERSOFT receive FDA 510(k) clearance?

VIPERSOFT received FDA 510(k) clearance on 1999-02-10, under 510(k) number K984030.

Who is the listed applicant for VIPERSOFT?

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

What is the FDA product code for VIPERSOFT?

The FDA product code for VIPERSOFT is EHD.

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 Integra Medical 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.

K981534VIPERCAM

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

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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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