ENSITE 3000 SYSTEM
FDA 510(k) clearance K983456 · decided 1999-04-21
Clearance details
- K-number
- K983456
- Device name
- ENSITE 3000 SYSTEM
- Applicant
- Endocardial Solutions, Inc.
- Decision
- Unknown
- Date received
- 1998-09-30
- Decision date
- 1999-04-21
- Days to decision
- 203 days
- Clearance type
- Traditional
- 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
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.