External Counterpulsation System
FDA 510(k) clearance K190683 · decided 2019-09-10
Clearance details
- K-number
- K190683
- Device name
- External Counterpulsation System
- Applicant
- Vamed Medical Instrument Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2019-03-18
- Decision date
- 2019-09-10
- Days to decision
- 176 days
- Clearance type
- Traditional
- Product code
- DRN
- Device class
- 2
- Regulation number
- 870.5225
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Foshan, CN
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Vamed Medical Instrument Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.