LONG LIFE PADTM— 510(k) K120516
Substantially EquivalentOmron Healthcare, Inc.
FDA 510(k) clearance K120516 for LONG LIFE PADTM, Substantially Equivalent on 2012-05-17. Applicant: Omron Healthcare, Inc.. Device class: 2.
Clearance details
- Applicant
- Omron Healthcare, Inc.
- Product code
- Code GXY
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bonita Springs, FL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.