PRACTICAL COMPRESSION DEVICE (PCD) 901A&901B
FDA 510(k) clearance K121962 · decided 2012-10-19
Clearance details
- K-number
- K121962
- Device name
- PRACTICAL COMPRESSION DEVICE (PCD) 901A&901B
- Applicant
- Mego Afek AC , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2012-07-05
- Decision date
- 2012-10-19
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- JOW
- Device class
- 2
- Regulation number
- 870.5800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Afek, IL
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Mego Afek AC
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.