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FDA 510(k)

PE ELECTROPHYSIOLOGY LAB SYSTEM (PEEP)

K-Number: K902716 · 1990-09-04

ApplicantPrucka Engineering, Inc.
Decision Date1990-09-04
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PE ELECTROPHYSIOLOGY LAB SYSTEM (PEEP) is the device name listed in this FDA 510(k) record. The listed applicant is Prucka Engineering, Inc.. It received FDA 510(k) clearance on 1990-09-04 under 510(k) number K902716. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PE ELECTROPHYSIOLOGY LAB SYSTEM (PEEP)?

PE ELECTROPHYSIOLOGY LAB SYSTEM (PEEP) is a medical device that received FDA 510(k) clearance on 1990-09-04. The listed applicant is Prucka Engineering, Inc.. The 510(k) number is K902716.

When did PE ELECTROPHYSIOLOGY LAB SYSTEM (PEEP) receive FDA 510(k) clearance?

PE ELECTROPHYSIOLOGY LAB SYSTEM (PEEP) received FDA 510(k) clearance on 1990-09-04, under 510(k) number K902716.

Who is the listed applicant for PE ELECTROPHYSIOLOGY LAB SYSTEM (PEEP)?

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

What is the FDA product code for PE ELECTROPHYSIOLOGY LAB SYSTEM (PEEP)?

The FDA product code for PE ELECTROPHYSIOLOGY LAB SYSTEM (PEEP) is DQK.

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 Prucka Engineering, 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.

K993414PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2K960321CARDIOCATH CATHETERIZATION LAB SYSTEMK904747PEI PLAQUE ELECTRODE ARRAYK910307CARDIOLAB AMPLIFIER MODULE (CAM)K895916PE INTERCARDIAC MAPPING SYSTEM (ICMS)

Related Devices (Code: DQK)

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.

K261729EnSite™ X EP SystemAbbott MedicalK262005Affera Integrated Mapping SystemMedtronic, Inc.K253692AVVIGO™+ Multi-Modality Guidance SystemBoston ScientificK253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, 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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