INFINITY DELTA AND KAPPA SERIES MONITORS WITH VF6 MODIFICATIONS
FDA 510(k) clearance K060039 · decided 2006-04-12
Clearance details
- K-number
- K060039
- Device name
- INFINITY DELTA AND KAPPA SERIES MONITORS WITH VF6 MODIFICATIONS
- Applicant
- Draeger Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-01-06
- Decision date
- 2006-04-12
- Days to decision
- 96 days
- Clearance type
- Special
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Danvers, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Draeger Medical Systems
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 |
|---|---|---|
| Infinity Docking Station (IDS) Delta and Kappa Series patient Monitors. Model numbers 4715 recall (Z-0301-2007) | Draeger Medical, Inc. | 2006-12-19 |