MYLABSOGNO
FDA 510(k) clearance K121384 · decided 2012-05-23
Clearance details
- K-number
- K121384
- Device name
- MYLABSOGNO
- Applicant
- Esaote, S.p.A.
- Decision
- Substantially Equivalent
- Date received
- 2012-05-08
- Decision date
- 2012-05-23
- Days to decision
- 15 days
- Clearance type
- Special
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Indianpolis, IN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Esaote
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 |
|---|---|---|
| Siemens Medical Solutions, ACUSON P300 Ultrasound system with P300 PA 230E cardiac probe ( recall (Z-1331-2014) | Siemens Medical Solutions USA, Inc. | 2014-04-03 |