Eecp Therapy System Model TS3 with Pulse Oximetry and Enhanced External Counterpulsation Eecp MC-2 External Counter
FDA 510(k) K020857 · Vasomedical, Inc.
510(k) numberK020857
Submission
- Device name
- Eecp Therapy System Model TS3 with Pulse Oximetry and Enhanced External Counterpulsation Eecp MC-2 External Counter
- Applicant
- Vasomedical, Inc.
Westbury, NY, US - Received
- March 18, 2002
- Decision date
- June 14, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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.
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|---|---|---|
| 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 |
| K003469 | Eecp Therapy System, Model TS3DRN · Special | 12/06/2000SE |
Questions and answers
When was Eecp Therapy System Model TS3 with Pulse Oximetry and Enhanced External Counterpulsation Eecp MC-2 External Counter cleared by the FDA?
Eecp Therapy System Model TS3 with Pulse Oximetry and Enhanced External Counterpulsation Eecp MC-2 External Counter (K020857) received a 510(k) decision of Substantially Equivalent on June 14, 2002, 88 days after the submission was received.
What is the product code of K020857?
The FDA product code is DRN – Device, Counter-Pulsating, External, a Class II (moderate risk) device regulated under 21 CFR 870.5225.