FDA 510(k)

EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL COUNTERPULSATION EECP MC-2 EXTERNAL COUNTER

K-Number: K020857 · 2002-06-14

Decision Date2002-06-14

Product CodeDRN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL COUNTERPULSATION EECP MC-2 EXTERNAL COUNTER is the device name listed in this FDA 510(k) record. The listed applicant is Vasomedical, Inc.. It received FDA 510(k) clearance on 2002-06-14 under 510(k) number K020857. 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 TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL COUNTERPULSATION EECP MC-2 EXTERNAL COUNTER?

EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL COUNTERPULSATION EECP MC-2 EXTERNAL COUNTER is a medical device that received FDA 510(k) clearance on 2002-06-14. The listed applicant is Vasomedical, Inc.. The 510(k) number is K020857.

When did EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL COUNTERPULSATION EECP MC-2 EXTERNAL COUNTER receive FDA 510(k) clearance?

EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL COUNTERPULSATION EECP MC-2 EXTERNAL COUNTER received FDA 510(k) clearance on 2002-06-14, under 510(k) number K020857.

Who is the listed applicant for EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL COUNTERPULSATION EECP MC-2 EXTERNAL COUNTER?

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 TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL COUNTERPULSATION EECP MC-2 EXTERNAL COUNTER?

The FDA product code for EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL COUNTERPULSATION EECP MC-2 EXTERNAL COUNTER 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.