Volume Ventilator
FDA 510(k) K942572 · Med-Plastics Intl., Inc.
510(k) numberK942572
Submission
- Device name
- Volume Ventilator
- Applicant
- Med-Plastics Intl., Inc.
Indianapolis, IN, US - Received
- May 31, 1994
- Decision date
- June 10, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| K942569 | Ventilator HoseBZO · Traditional | Med-Plastics Intl., Inc. | 06/10/1994SE |
| K935582 | Tube, Inhaler OxygenBZO · Traditional | Puritas Health Care, Inc. | 01/14/1994SE |
More from Puritas Health Care, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K946209 | Dispodable Heat & Moisture Exchanger and Filter/HmeBYD · Traditional | 06/08/1995SE |
| K942571 | Hyper-Inflation BagNHK · Traditional | 06/10/1994SE |
| K942570 | Mapleson D CircuitCAI · Traditional | 06/10/1994SE |
| K942569 | Ventilator HoseBZO · Traditional | 06/10/1994SE |
| K942568 | Adult Anesthesia Breathing CircuitCAI · Traditional | 06/10/1994SE |
| K942567 | Mass Spectrometry Monitoring Lines and ConnectorsCCK · Traditional | 06/10/1994SE |
| K932578 | Adult Gas Sampling CircuitsCAI · Traditional | 07/22/1993SE |
| K932577 | Pediatric Gas SamplingCAI · Traditional | 07/22/1993SE |
| K932576 | Pediatric Temperature Monitoring CircuitsCAI · Traditional | 07/22/1993SE |
| K932575 | Adult Temperature Monitoring Anesthesia CircuitsCAI · Traditional | 07/22/1993SE |
Questions and answers
When was Volume Ventilator cleared by the FDA?
Volume Ventilator (K942572) received a 510(k) decision of Substantially Equivalent on June 10, 1994, 10 days after the submission was received.
What is the product code of K942572?
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.