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FDA 510(k)

SOPRO595 INTRA ORAL CAMERA

K-Number: K012505 · 2001-10-05

ApplicantSopro
Decision Date2001-10-05
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SOPRO595 INTRA ORAL CAMERA is the device name listed in this FDA 510(k) record. The listed applicant is Sopro. It received FDA 510(k) clearance on 2001-10-05 under 510(k) number K012505. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOPRO595 INTRA ORAL CAMERA?

SOPRO595 INTRA ORAL CAMERA is a medical device that received FDA 510(k) clearance on 2001-10-05. The listed applicant is Sopro. The 510(k) number is K012505.

When did SOPRO595 INTRA ORAL CAMERA receive FDA 510(k) clearance?

SOPRO595 INTRA ORAL CAMERA received FDA 510(k) clearance on 2001-10-05, under 510(k) number K012505.

Who is the listed applicant for SOPRO595 INTRA ORAL CAMERA?

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

What is the FDA product code for SOPRO595 INTRA ORAL CAMERA?

The FDA product code for SOPRO595 INTRA ORAL CAMERA is EIA.

Related Clinical Trials

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Other records listing Sopro 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.

K223470C50K121685SOPROCAREK103813SOPRO 281K092329SOPIX 2K092583SOPROLIFEK082796SOPRO 184 CAMERA

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Related Devices (Code: EIA)

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.

K251544Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)Lakong Medical Devices Co., Ltd.K251626Midmark Dental Delivery SystemMidmark CorporationK251491K5 Cart, K5 Mount, K5 SwingOsstem Implant Company., Ltd. Chair BusinessK243130Integral Dental UnitGuangdong Yadeng Medical Apparatus Co., Ltd.,K242611Integral Dental UnitsMipont Medical Equipment Co., Ltd.K250473Dental Delivery System Series 5 and Dental Delivery System Series 5 PlusDci International, LLC

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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