ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS
FDA 510(k) clearance K133604 · decided 2014-01-10
Clearance details
- K-number
- K133604
- Device name
- ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS
- Applicant
- The Anspach Effort, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-11-25
- Decision date
- 2014-01-10
- Days to decision
- 46 days
- Clearance type
- Special
- Product code
- HBC
- Device class
- 2
- Regulation number
- 882.4360
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Palm Beach Gardens, FL, US
- Third-party review
- No
- Expedited review
- No
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