Revian Lyte (10011)— 510(k) K242441
Substantially EquivalentRevian, Inc.
FDA 510(k) clearance K242441 for Revian Lyte (10011), Substantially Equivalent on 2024-09-13. Applicant: Revian, Inc.. Device class: 2.
Clearance details
- Applicant
- Revian, Inc.
- Product code
- Code OAP
- Device class
- Class 2
- Regulation
- 21 CFR 890.5500
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Morrisville, NC, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.