EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL COUNTERPULSATION EECP MC-2 EXTERNAL COUNTER— 510(k) K020857
Substantially EquivalentVasomedical, Inc.
FDA 510(k) clearance K020857 for EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL COUNTERPULSATION EECP MC-2 EXTERNAL COUNTER, Substantially Equivalent on 2002-06-14. Applicant: Vasomedical, Inc.. Device class: 2.
Clearance details
- Applicant
- Vasomedical, Inc.
- Product code
- Code DRN
- Device class
- Class 2
- Regulation
- 21 CFR 870.5225
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westbury, NY, US
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