EAR ELECTRODE-ADULT & PEDIATRIC— 510(k) K780537
Substantially EquivalentLife-Tech Instruments, Inc.
FDA 510(k) clearance K780537 for EAR ELECTRODE-ADULT & PEDIATRIC, Substantially Equivalent on 1978-06-02. Applicant: Life-Tech Instruments, Inc.. Device class: 2.
Clearance details
- Applicant
- Life-Tech Instruments, 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
- Mchenry, IL, US
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