SILENT NIGHT I— 510(k) K963597
Substantially EquivalentLocal Silence, Inc.
FDA 510(k) clearance K963597 for SILENT NIGHT I, Substantially Equivalent on 1997-01-23. Applicant: Local Silence, Inc.. Device class: 2.
Clearance details
- Applicant
- Local Silence, Inc.
- Product code
- Code MNR
- Device class
- Class 2
- Regulation
- 21 CFR 868.2375
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Altos, CA, US
Recent devices under product code MNR
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