ACUSYST-JR— 510(k) K872086
Substantially EquivalentEndotronics, Inc.
FDA 510(k) clearance K872086 for ACUSYST-JR, Substantially Equivalent on 1987-06-15. Applicant: Endotronics, Inc.. Device class: 1.
Clearance details
- Applicant
- Endotronics, Inc.
- Product code
- Code KJH
- Device class
- Class 1
- Regulation
- 21 CFR 864.2240
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Coon Rapids, MN, US
Recent devices under product code KJH
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