Criterion I.V. Ventilator Breathing Circuit #1004
FDA 510(k) K893760 · Nova-Ventrx
510(k) numberK893760
Submission
- Device name
- Criterion I.V. Ventilator Breathing Circuit #1004
- Applicant
- Nova-Ventrx
Wheeling, IL, US - Received
- May 19, 1989
- Decision date
- August 10, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZO – Set, Tubing And Support, Ventilator (W Harness)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5975
- Specialty
- Anesthesiology
Other 510(k)s with product code BZO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K953784 | Unicor, Inc. Corrugated TubingBZO · Traditional | Unicor, Inc. | 09/19/1995SE |
| K953785 | Unicor, Inc. Ventilator HosesBZO · Traditional | Unicor, Inc. | 09/18/1995SE |
| K952022 | Prima Volumn VentilatorssBZO · Traditional | Prima, Inc. | 05/22/1995SE |
| K952012 | Prima Custom Anestesia CircuitBZO · Traditional | Prima, Inc. | 05/22/1995SE |
| K952011 | Prima Breathing BagsBZO · Traditional | Prima, Inc. | 05/22/1995SE |
| K952010 | Prima Ventilator HosesBZO · Traditional | Prima, Inc. | 05/22/1995SE |
| K945740 | Infant Flow SystemBZO · Traditional | Hamilton Medical, Inc. | 03/23/1995SE |
| K944531 | Prima, Inc. Corrugated TubingBZO · Traditional | Prima, Inc. | 12/02/1994SE |
| K942572 | Volume VentilatorBZO · Traditional | Med-Plastics Intl., Inc. | 06/10/1994SE |
| K942569 | Ventilator HoseBZO · Traditional | Med-Plastics Intl., Inc. | 06/10/1994SE |
More from Med-Plastics Intl., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K952267 | Criterion, Criterion I.V., ModifiedBZE · Traditional | 12/02/1997SE |
| K954480 | Condensate Collection KitCAI · Traditional | 12/29/1995SE |
| K881207 | Res-Q 1, 2, 3, 4 and 5BTM · Traditional | 08/15/1988SE |
| K870382 | DRV Disp Resuscit 3000/BAG Adapt 3010 & 3011CBP · Traditional | 03/06/1987SE |
| K863756 | Modified Criterion Ventilator Breathing CircuitBZO · Traditional | 11/13/1986SE |
| K850600 | Co-Ax Ventilator CircuitBZO · Traditional | 05/02/1985SE |
| K842795 | Maxi-Miser Humidifier Insert 1030BTT · Traditional | 10/04/1984SE |
| K842794 | Maxi-Miser Humidifier Insert 1020 & 1021BTT · Traditional | 10/04/1984SE |
| K841571 | Maxi-Miser Water Transfer Set 1021/1022 · Traditional | 05/30/1984SE |
| K841569 | Maxi-Miser Humidifier Insert 1020 · Traditional | 05/30/1984SE |
Questions and answers
When was Criterion I.V. Ventilator Breathing Circuit #1004 cleared by the FDA?
Criterion I.V. Ventilator Breathing Circuit #1004 (K893760) received a 510(k) decision of Substantially Equivalent on August 10, 1989, 83 days after the submission was received.
What is the product code of K893760?
The FDA product code is BZO – Set, Tubing And Support, Ventilator (W Harness), a Class I (low risk) device regulated under 21 CFR 868.5975.