KJH
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Apparatus, Perfusion
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.2240
- Medical specialty
- Hematology
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1992: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ACUSYST-P/3X (K875151) | Endotronics, Inc. | 1988-01-12 |
| ACUSYST-JR (K872086) | Endotronics, Inc. | 1987-06-15 |
| ACUSYST-P (CELL CULTURE EQUIPMENT) (K864334) | Endotronics, Inc. | 1986-11-24 |
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Every clearance here is in the API, with alerts when new ones post.