INFANT FLOW SYSTEM
FDA 510(k) clearance K945740 · decided 1995-03-23
Clearance details
- K-number
- K945740
- Device name
- INFANT FLOW SYSTEM
- Applicant
- Hamilton Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-11-23
- Decision date
- 1995-03-23
- Days to decision
- 120 days
- Clearance type
- Traditional
- Product code
- BZO
- Device class
- 1
- Regulation number
- 868.5975
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Reno, NV, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| UNICOR, INC. CORRUGATED TUBING (K953784) | Unicor, Inc. | 1995-09-19 |
| UNICOR, INC. VENTILATOR HOSES (K953785) | Unicor, Inc. | 1995-09-18 |
| PRIMA VENTILATOR HOSES (K952010) | Prima, Inc. | 1995-05-22 |
| PRIMA VOLUMN VENTILATORSS (K952022) | Prima, Inc. | 1995-05-22 |
| PRIMA CUSTOM ANESTESIA CIRCUIT (K952012) | Prima, Inc. | 1995-05-22 |
| PRIMA BREATHING BAGS (K952011) | Prima, Inc. | 1995-05-22 |
| PRIMA, INC. CORRUGATED TUBING (K944531) | Prima, Inc. | 1994-12-02 |
| VENTILATOR HOSE (K942569) | Med-Plastics Intl., Inc. | 1994-06-10 |
| VOLUME VENTILATOR (K942572) | Med-Plastics Intl., Inc. | 1994-06-10 |
| TUBE, INHALER OXYGEN (K935582) | Puritas Health Care, Inc. | 1994-01-14 |
| STAR BREATHING CIRCUITS (K934753) | Infrasonics Corp. | 1993-10-27 |
| PRECISION MED PRODUCTS LTD. VENTILATOR HOSE (K932706) | Precision Med Products, Ltd. | 1993-07-23 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Hamilton Medical Infant Flow Sensor, single use, (1.6m), Part number 260177. The infant fl recall (Z-1963-2015) | Hamilton Medical, Inc. | 2015-07-02 |
| Hamilton Medical Infant Flow Sensor, single use, (1.88m), Part number 155500. The infant f recall (Z-1964-2015) | Hamilton Medical, Inc. | 2015-07-02 |
| Hamilton Medical Infant Flow Sensor, single use, (3.1m), Part number 260179. The infant fl recall (Z-1965-2015) | Hamilton Medical, Inc. | 2015-07-02 |