JRG
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Block, Heating
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2050
- Medical specialty
- Clinical Chemistry
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1997: 2
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 |
|---|---|---|
| BLOOD GAS INCUBATOR #260650 (K823766) | Boekel Industries, Inc. | 1983-02-18 |
| HEATING BLOCK, WAMPOLE 37 C (K790549) | Armkel, LLC | 1979-05-03 |
| ENZAC INCUBATOR (K781501) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-10-03 |
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Every clearance here is in the API, with alerts when new ones post.