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FDA 510(k)

PRO-SCOPE MODEL # PS-4000

K-Number: K922942 · 1993-09-10

ApplicantPro-Den Systems, Inc.
Decision Date1993-09-10
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PRO-SCOPE MODEL # PS-4000 is the device name listed in this FDA 510(k) record. The listed applicant is Pro-Den Systems, Inc.. It received FDA 510(k) clearance on 1993-09-10 under 510(k) number K922942. 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 PRO-SCOPE MODEL # PS-4000?

PRO-SCOPE MODEL # PS-4000 is a medical device that received FDA 510(k) clearance on 1993-09-10. The listed applicant is Pro-Den Systems, Inc.. The 510(k) number is K922942.

When did PRO-SCOPE MODEL # PS-4000 receive FDA 510(k) clearance?

PRO-SCOPE MODEL # PS-4000 received FDA 510(k) clearance on 1993-09-10, under 510(k) number K922942.

Who is the listed applicant for PRO-SCOPE MODEL # PS-4000?

The FDA 510(k) record lists Pro-Den Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRO-SCOPE MODEL # PS-4000?

The FDA product code for PRO-SCOPE MODEL # PS-4000 is EIA.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Pro-Den Systems, Inc. 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.

K954061POLY-LITE MODEL 1000

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

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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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