VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM
FDA 510(k) clearance K031077 · decided 2003-12-11
Clearance details
- K-number
- K031077
- Device name
- VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM
- Applicant
- Chattanooga Group
- Decision
- Substantially Equivalent
- Date received
- 2003-04-04
- Decision date
- 2003-12-11
- Days to decision
- 251 days
- Clearance type
- Traditional
- Product code
- IMG
- Device class
- 2
- Regulation number
- 890.5860
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Hixson, TN, US
- Third-party review
- No
- Expedited review
- No
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