OMNI-TRAC MODIFICATION— 510(k) K935020
Substantially EquivalentInvivo Research, Inc.
FDA 510(k) clearance K935020 for OMNI-TRAC MODIFICATION, Substantially Equivalent on 1995-04-26. Applicant: Invivo Research, Inc.. Device class: 2.
Clearance details
- Applicant
- Invivo Research, Inc.
- Product code
- Code MLD
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Orlando, FL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.