MULTIPLE NAME
FDA 510(k) clearance K123819 · decided 2013-03-05
Clearance details
- K-number
- K123819
- Device name
- MULTIPLE NAME
- Applicant
- Top Calibre Sdn Bhd
- Decision
- Substantially Equivalent
- Date received
- 2012-12-12
- Decision date
- 2013-03-05
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- LYY
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Shah Alam, MY
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Top Calibre Sdn Bhd
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.