FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENSITE 3000 SYSTEM, MODEL EE3000
K Number: K001437
·
Decision Jun 7, 2000
Classifications
1
FEI Numbers
178
Registration Numbers
178
Same Product Code
429
Applicant Total
8
Review Days
30
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Basic Information
- Device Name
- ENSITE 3000 SYSTEM, MODEL EE3000
- K Number
- K001437
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1425
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Endocardial Solutions, Inc.
- Date Received
- May 8, 2000
- Decision Date
- June 7, 2000
- Product Code
- DQK
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | FDA class 2 | Cardiovascular |
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Other Clearances by Endocardial Solutions, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K042493 | ENSITE SYSTEM, MODEL EE3000 | Oct 15, 2004 | Substantially Equivalent |
| K033211 | ENSITE SYSTEM | Oct 30, 2003 | Substantially Equivalent |
| K030129 | MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000 | Apr 22, 2003 | Unknown |
| K012926 | MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000 | Sep 28, 2001 | Unknown |
| K993376 | ENSTYLET MODELS EC0010, EC0020 | Jan 5, 2000 | Substantially Equivalent |
| K992479 | ENSITE 3000 SYSTEM | Dec 2, 1999 | Unknown |
| K983456 | ENSITE 3000 SYSTEM | Apr 21, 1999 | Unknown |