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FDA 510(k)

CARDIOLAB AMPLIFIER MODULE (CAM)

K-Number: K910307 · 1991-04-12

ApplicantPrucka Engineering, Inc.
Decision Date1991-04-12
Product CodeDRR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOLAB AMPLIFIER MODULE (CAM) 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 1991-04-12 under 510(k) number K910307. The device is classified under product code DRR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOLAB AMPLIFIER MODULE (CAM)?

CARDIOLAB AMPLIFIER MODULE (CAM) is a medical device that received FDA 510(k) clearance on 1991-04-12. The listed applicant is Prucka Engineering, Inc.. The 510(k) number is K910307.

When did CARDIOLAB AMPLIFIER MODULE (CAM) receive FDA 510(k) clearance?

CARDIOLAB AMPLIFIER MODULE (CAM) received FDA 510(k) clearance on 1991-04-12, under 510(k) number K910307.

Who is the listed applicant for CARDIOLAB AMPLIFIER MODULE (CAM)?

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 CARDIOLAB AMPLIFIER MODULE (CAM)?

The FDA product code for CARDIOLAB AMPLIFIER MODULE (CAM) is DRR.

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 ARRAYK902716PE ELECTROPHYSIOLOGY LAB SYSTEM (PEEP)K895916PE INTERCARDIAC MAPPING SYSTEM (ICMS)

Related Devices (Code: DRR)

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.

K022660BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117Biocheck, Inc.K971570EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391Quinton Electrophysiology Corp.K925346EP AMP, MODEL #901Quinton Electrophysiology Corp.K914381HORIZON 9000/HIS OPTION AMPLIFIERMennen Medical, Inc.K911935CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIEDGould, Inc.K894735ASC-952 PHYSIOLOGICAL AMPLIFIERAstro-Med, Inc.

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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