ROSS EMBRACE ENTERAL PUMP
FDA 510(k) clearance K031407 · decided 2003-05-20
Clearance details
- K-number
- K031407
- Device name
- ROSS EMBRACE ENTERAL PUMP
- Applicant
- Ross Product Div. Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 2003-05-05
- Decision date
- 2003-05-20
- Days to decision
- 15 days
- Clearance type
- Special
- Product code
- LZH
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Columbus, OH, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ross Product Div. Abbott Laboratories
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 |
|---|---|---|
| Embrace Enteral Pump recall (Z-1141-2007) | Ross Products Division Abbott Laboratories | 2007-08-08 |