Eecp Therapy System, Model TS3
FDA 510(k) K003469 · Vasomedical, Inc.
510(k) numberK003469
Submission
- Device name
- Eecp Therapy System, Model TS3
- Applicant
- Vasomedical, Inc.
Westbury, NY, US - Received
- November 8, 2000
- Decision date
- December 6, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRN – Device, Counter-Pulsating, External
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5225
- Specialty
- Cardiovascular
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More from Ecp Health, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K111180 | Vasomedical-Biox 12- Channel Ambulatory ECG Holter Recorder Model 1304, Vasomedical-Biox…DSH · Special | 06/28/2011SE |
| K111096 | Vasomedical-Biox Combined 12 Channel Ambulatory ECG and Blood Pressure Recorder Model…DSH · Special | 06/24/2011SE |
| K092785 | Combined Vasomedical-Biox Ambulatory ECG & Blood Pressure Recorder & Analysis Software…DSH · Traditional | 04/02/2010SE |
| K083820 | Vasomedical Biox CB-1305-C, 3 Channel ECG Holter Monitor, Model CB-1305-CDSH · Traditional | 04/01/2009SE |
| K033617 | Eecp Therapy System Model TS4 With/Without Pluse OximetryDRN · Traditional | 03/01/2004SE |
| K020857 | Eecp Therapy System Model TS3 with Pulse Oximetry and Enhanced External Counterpulsation…DRN · Traditional | 06/14/2002SE |
Questions and answers
When was Eecp Therapy System, Model TS3 cleared by the FDA?
Eecp Therapy System, Model TS3 (K003469) received a 510(k) decision of Substantially Equivalent on December 6, 2000, 28 days after the submission was received.
What is the product code of K003469?
The FDA product code is DRN – Device, Counter-Pulsating, External, a Class II (moderate risk) device regulated under 21 CFR 870.5225.