BZO · Set, Tubing And Support, Ventilator (W Harness)
Anesthesiology · 21 CFR 868.5975 · Class 1
Overview
| Product Code | BZO |
|---|---|
| Device Name | Set, Tubing And Support, Ventilator (W Harness) |
| Regulation | 21 CFR 868.5975 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
Ventilator tubing is a device intended for use as a conduit for gases between a ventilator and a patient during ventilation of the patient.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
Recent Cleared Devices (20 of 88)
Showing 20 most recent of 88 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K953784 | UNICOR, INC. CORRUGATED TUBING | Unicor, Inc. | Sep 19, 1995 | SESE |
| K953785 | UNICOR, INC. VENTILATOR HOSES | Unicor, Inc. | Sep 18, 1995 | SESE |
| K952022 | PRIMA VOLUMN VENTILATORSS | Prima, Inc. | May 22, 1995 | SESE |
| K952012 | PRIMA CUSTOM ANESTESIA CIRCUIT | Prima, Inc. | May 22, 1995 | SESE |
| K952011 | PRIMA BREATHING BAGS | Prima, Inc. | May 22, 1995 | SESE |
| K952010 | PRIMA VENTILATOR HOSES | Prima, Inc. | May 22, 1995 | SESE |
| K945740 | INFANT FLOW SYSTEM | Hamilton Medical, Inc. | Mar 23, 1995 | SESE |
| K944531 | PRIMA, INC. CORRUGATED TUBING | Prima, Inc. | Dec 2, 1994 | SESE |
| K942572 | VOLUME VENTILATOR | Med-Plastics Intl., Inc. | Jun 10, 1994 | SESE |
| K942569 | VENTILATOR HOSE | Med-Plastics Intl., Inc. | Jun 10, 1994 | SESE |
| K935582 | TUBE, INHALER OXYGEN | Puritas Health Care, Inc. | Jan 14, 1994 | SESE |
| K934753 | STAR BREATHING CIRCUITS | Infrasonics Corp. | Oct 27, 1993 | SESE |
| K932706 | PRECISION MED PRODUCTS LTD. VENTILATOR HOSE | Precision Med Products, Ltd. | Jul 23, 1993 | SESE |
| K932712 | PRECISION MED PRODUCTS LTD VOLUME VENTILATORS | Precision Med Products, Ltd. | Jul 22, 1993 | SESE |
| K932560 | VOLUME VENTILATORS | Life Shield Healthcare Products, Inc. | Jul 22, 1993 | SESE |
| K932563 | VENTILATOR HOSES | Life Shield Healthcare Products, Inc. | Jul 16, 1993 | SESE |
| K932119 | CLEVELAND TUBING, INC. VENTILATOR HOSES | Cleveland Tubing, Inc. | Jun 23, 1993 | SESE |
| K922479 | DISPOSABLE ANESTHESIA BREATHING CIRCUIT, MODIFIED | Intertech Resources, Inc. | Oct 30, 1992 | SESE |
| K921510 | GAS SAMPLING KIT MODIFICATION | Respiratory Support Products, Inc. | Jun 11, 1992 | SESE |
| K911328 | UNIVERSAL VOLUME VENTILATOR CIRCUIT, MODIFICATION | Intertech Resources, Inc. | Aug 15, 1991 | SESE |
Top Applicants
- Prima, Inc. — 5 clearances
- Airlife, Inc. — 5 clearances
- Nova-Ventrx — 4 clearances
- Dryden Corp. — 3 clearances
- Cygnus Research Corp. — 3 clearances
