SOCRATES ROBOTIC TELEMONITORING SYSTEM
FDA 510(k) clearance K003661 · decided 2001-10-05
Clearance details
- K-number
- K003661
- Device name
- SOCRATES ROBOTIC TELEMONITORING SYSTEM
- Applicant
- Computer Motion, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-11-28
- Decision date
- 2001-10-05
- Days to decision
- 311 days
- Clearance type
- Traditional
- Product code
- NEQ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Goleta, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SOCRATES ROBOTIC TELEMONITORING SYSTEM (K013804) | Computer Motion, Inc. | 2001-12-10 |
Recalls involving this device
No recalls on record reference this clearance.