Elcam Stopcocks and Manifolds— 510(k) K190489
Substantially EquivalentElcam Medical Acal
FDA 510(k) clearance K190489 for Elcam Stopcocks and Manifolds, Substantially Equivalent on 2019-04-23. Applicant: Elcam Medical Acal. Device class: 2.
Clearance details
- Applicant
- Elcam Medical Acal
- Product code
- Code FMG
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- -, IL
Recent devices under product code FMG
view allMore clearances from Elcam Medical Acal
view all- K231900 — A-TAP (previously called Arthrotap)
- K141254 — ELCAM STOPCOCKS AND MANIFOLDS
- K123084 — DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD
- K120253 — ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS)
- K120624 — ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT)
Adverse events under product code FMG
product code FMG- Death
- 14
- Malfunction
- 3,433
- Other
- 1
- Total
- 3,448
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.