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FDA 510(k)

PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2

K-Number: K993414 · 2000-04-07

ApplicantPrucka Engineering, Inc.
Decision Date2000-04-07
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2 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 2000-04-07 under 510(k) number K993414. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2?

PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2 is a medical device that received FDA 510(k) clearance on 2000-04-07. The listed applicant is Prucka Engineering, Inc.. The 510(k) number is K993414.

When did PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2 receive FDA 510(k) clearance?

PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2 received FDA 510(k) clearance on 2000-04-07, under 510(k) number K993414.

Who is the listed applicant for PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2?

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 PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2?

The FDA product code for PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2 is DPS.

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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.

K960321CARDIOCATH CATHETERIZATION LAB SYSTEMK904747PEI PLAQUE ELECTRODE ARRAYK910307CARDIOLAB AMPLIFIER MODULE (CAM)K902716PE ELECTROPHYSIOLOGY LAB SYSTEM (PEEP)K895916PE INTERCARDIAC MAPPING SYSTEM (ICMS)

Related Devices (Code: DPS)

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.

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France Commercial

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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