FDA 510(k)

EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY

K-Number: K033617 · 2004-03-01

Decision Date2004-03-01

Product CodeDRN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY is the device name listed in this FDA 510(k) record. The listed applicant is Vasomedical, Inc.. It received FDA 510(k) clearance on 2004-03-01 under 510(k) number K033617. The device is classified under product code DRN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY?

EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY is a medical device that received FDA 510(k) clearance on 2004-03-01. The listed applicant is Vasomedical, Inc.. The 510(k) number is K033617.

When did EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY receive FDA 510(k) clearance?

EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY received FDA 510(k) clearance on 2004-03-01, under 510(k) number K033617.

Who is the listed applicant for EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY?

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

What is the FDA product code for EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY?

The FDA product code for EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY is DRN.

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Other records listing Vasomedical, Inc. as applicant

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Related Devices (Code: DRN)

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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.