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FDA 510(k)

PRENVAL I

K-Number: K953652 · 1995-09-15

ApplicantBase Ten Systems, Inc.
Decision Date1995-09-15
Product CodeJQP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PRENVAL I is the device name listed in this FDA 510(k) record. The listed applicant is Base Ten Systems, Inc.. It received FDA 510(k) clearance on 1995-09-15 under 510(k) number K953652. The device is classified under product code JQP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRENVAL I?

PRENVAL I is a medical device that received FDA 510(k) clearance on 1995-09-15. The listed applicant is Base Ten Systems, Inc.. The 510(k) number is K953652.

When did PRENVAL I receive FDA 510(k) clearance?

PRENVAL I received FDA 510(k) clearance on 1995-09-15, under 510(k) number K953652.

Who is the listed applicant for PRENVAL I?

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

What is the FDA product code for PRENVAL I?

The FDA product code for PRENVAL I is JQP.

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 Base Ten 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.

K961160UPACS VERSION 1.7K960941UPACS

Related Devices (Code: JQP)

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.

K113007BIONIME DIABETES MANAGEMENT SYSTEM VI.0Bionime CorporationK983468FASTTAKE ADAPTER, MODEL # P/N 020-072-01Selfcare, Inc.K964460THE ROBOLITEShai Syg Motion and Innovations, Ltd.K934111MR7000 WITH TIME MANAGER SOFTWARE (TMS)Dynatech Laboratories, Inc.K923316EXPRESSO CARTRIDGEBio-Rad Laboratories, Inc.K893838MODIFIED MODEL 570 CLINICAL CHEMISTRY ANALYZERCiba Corning Diagnostics Corp.

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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