ACTIVECARE ++ SYSTEM
FDA 510(k) clearance K060146 · decided 2006-03-08
Clearance details
- K-number
- K060146
- Device name
- ACTIVECARE ++ SYSTEM
- Applicant
- Medical Compression Systems (Dbn) , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2006-01-19
- Decision date
- 2006-03-08
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- JOW
- Device class
- 2
- Regulation number
- 870.5800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Ramat Gan, IL
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Medical Compression Systems (Dbn)
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
| Record | Firm | Date |
|---|---|---|
| ActiveCare +SFT Medical Compression Systems OR Aqiva, IL Intended for use in: Preventing d recall (Z-0386-2012) | Medical Compression Systems | 2012-01-11 |