ActiSpec Activity Monitor
FDA 510(k) clearance K143512 · decided 2015-08-26
Clearance details
- K-number
- K143512
- Device name
- ActiSpec Activity Monitor
- Applicant
- Sleep Modus, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-12-11
- Decision date
- 2015-08-26
- Days to decision
- 258 days
- Clearance type
- Traditional
- Product code
- ISD
- Device class
- 2
- Regulation number
- 890.5360
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Richardson, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.