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FDA 510(k)

AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC

K-Number: K070985 · 2008-02-01

ApplicantOsypka Medical, Inc.
Decision Date2008-02-01
Product CodeDSB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC is the device name listed in this FDA 510(k) record. The listed applicant is Osypka Medical, Inc.. It received FDA 510(k) clearance on 2008-02-01 under 510(k) number K070985. The device is classified under product code DSB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC?

AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC is a medical device that received FDA 510(k) clearance on 2008-02-01. The listed applicant is Osypka Medical, Inc.. The 510(k) number is K070985.

When did AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC receive FDA 510(k) clearance?

AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC received FDA 510(k) clearance on 2008-02-01, under 510(k) number K070985.

Who is the listed applicant for AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC?

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

What is the FDA product code for AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC?

The FDA product code for AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC is DSB.

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Other records listing Osypka Medical, 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.

K123916PSA SERIESK082242ICON, MODEL C3K081035AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2K033130PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATORK022939OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIESK020896OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENE

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Related Devices (Code: DSB)

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.

K260224MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)ImpediMed LimitedK250634BCM2-Body Composition MonitorFresenius Medical Care Renal Therapies Group, LLCK243727Re:BalansMode Sensors ASK250922Edema Guard Monitor (EGM) CardioSet-001Cardioset Medical , Ltd.K232089SOZO ProImpediMed LimitedK223217Zynex Monitoring System, Model CM-1600Zynex Medical, 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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