V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM
FDA 510(k) clearance K141185 · decided 2014-06-06
Clearance details
- K-number
- K141185
- Device name
- V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2014-05-07
- Decision date
- 2014-06-06
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- DQK
- Device class
- 2
- Regulation number
- 870.1425
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Lowell, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Boston Scientific Corp
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.