BED ALERT— 510(k) K872522
Substantially EquivalentNite Train-R Enterprises, Inc.
FDA 510(k) clearance K872522 for BED ALERT, Substantially Equivalent on 1988-01-19. Applicant: Nite Train-R Enterprises, Inc.. Device class: 2.
Clearance details
- Applicant
- Nite Train-R Enterprises, Inc.
- Product code
- Code KPN
- Device class
- Class 2
- Regulation
- 21 CFR 876.2040
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newberg, OR, US
Recent devices under product code KPN
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