INFANT FLOW SYSTEM— 510(k) K945740
Substantially EquivalentHamilton Medical, Inc.
FDA 510(k) clearance K945740 for INFANT FLOW SYSTEM, Substantially Equivalent on 1995-03-23. Applicant: Hamilton Medical, Inc.. Device class: 1.
Clearance details
- Applicant
- Hamilton Medical, Inc.
- Product code
- Code BZO
- Device class
- Class 1
- Regulation
- 21 CFR 868.5975
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Reno, NV, US
Recent devices under product code BZO
view allMore clearances from Hamilton Medical, Inc.
view allRecalls naming K945740
K-number listed on FDA's recall record- Z-1963-2015 — Hamilton Medical Infant Flow Sensor, single use, (1.6m), Part number 260177. The infant flow sensor is an accessory for the Hamilton Medical Ventilators. Product Usage: The infant flow sensor is a device to measure patient air flow and pressures within the Hamilton Medical Ventilators.
- Z-1964-2015 — Hamilton Medical Infant Flow Sensor, single use, (1.88m), Part number 155500. The infant flow sensor is an accessory for the Hamilton Medical Ventilators. Product Usage: The infant flow sensor is a device to measure patient air flow and pressures within the Hamilton Medical Ventilators.
- Z-1965-2015 — Hamilton Medical Infant Flow Sensor, single use, (3.1m), Part number 260179. The infant flow sensor is an accessory for the Hamilton Medical Ventilators. Product Usage: The infant flow sensor is a device to measure patient air flow and pressures within the Hamilton Medical Ventilators.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K945740.
Data sourced from openFDA. This site is unofficial and independent of the FDA.