AMPCARE ESP THERAPY SYSTEM
FDA 510(k) clearance K131222 · decided 2013-10-31
Clearance details
- K-number
- K131222
- Device name
- AMPCARE ESP THERAPY SYSTEM
- Applicant
- Ampcare, LLC
- Decision
- Substantially Equivalent
- Date received
- 2013-04-30
- Decision date
- 2013-10-31
- Days to decision
- 184 days
- Clearance type
- Traditional
- Product code
- IPF
- Device class
- 2
- Regulation number
- 890.5850
- 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.