ASCEND
FDA 510(k) clearance K091155 · decided 2009-09-03
Clearance details
- K-number
- K091155
- Device name
- ASCEND
- Applicant
- Neurometrix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-04-21
- Decision date
- 2009-09-03
- Days to decision
- 135 days
- Clearance type
- Traditional
- Product code
- BXN
- Device class
- 2
- Regulation number
- 868.2775
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.