AUDIO MONITOR-MODEL 8309— 510(k) K780538
Substantially EquivalentLife-Tech Instruments, Inc.
FDA 510(k) clearance K780538 for AUDIO MONITOR-MODEL 8309, Substantially Equivalent on 1978-04-19. Applicant: Life-Tech Instruments, Inc.. Device class: 2.
Clearance details
- Applicant
- Life-Tech Instruments, Inc.
- Product code
- Code GWK
- Device class
- Class 2
- Regulation
- 21 CFR 882.1845
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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