MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000
FDA 510(k) clearance K012926 · decided 2001-09-28
Clearance details
- K-number
- K012926
- Device name
- MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000
- Applicant
- Endocardial Solutions, Inc.
- Decision
- Unknown
- Date received
- 2001-08-31
- Decision date
- 2001-09-28
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- MTD
- Device class
- 2
- Regulation number
- 870.1220
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Endocardial Solutions
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.