Precision Med Products Ltd Volume Ventilators
FDA 510(k) K932712 · Precision Med Products, Ltd.
510(k) numberK932712
Submission
- Device name
- Precision Med Products Ltd Volume Ventilators
- Applicant
- Precision Med Products, Ltd.
Marrtinsville, IN, US - Received
- June 4, 1993
- Decision date
- July 22, 1993
- 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 |
| 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 |
|---|---|---|
| K932711 | Precision Med Products Ltd Guedel AirwaysBTR · Traditional | 07/23/1993SE |
| K932710 | Gas Sampling Lines and ConnectorsCAI · Traditional | 07/23/1993SE |
| K932709 | Precision Med Products Ltd Hyperinflation SystemBZR · Traditional | 07/23/1993SE |
| K932708 | Precision Med Products Ltd Mapleson D CircuitsCAI · Traditional | 07/23/1993SE |
| K932707 | Adult Anesthesia Breathing CircuitCAI · Traditional | 07/23/1993SE |
| K932706 | Precision Med Products Ltd. Ventilator HoseBZO · Traditional | 07/23/1993SE |
| K932497 | Precision Med Products, Ltd. Adult Gas SamplingCAI · Traditional | 07/22/1993SE |
| K932489 | PMP, Ltd. Adult Temp. Monitoring Anesthesia Cir.CAI · Traditional | 07/22/1993SE |
| K932488 | PMP, Ltd. Pediatric Gas Sampling CircuitsCAI · Traditional | 07/22/1993SE |
| K932486 | PMP, Ltd. Pediatric Temperature Monitoring CircuitCAI · Traditional | 07/21/1993SE |
Questions and answers
When was Precision Med Products Ltd Volume Ventilators cleared by the FDA?
Precision Med Products Ltd Volume Ventilators (K932712) received a 510(k) decision of Substantially Equivalent on July 22, 1993, 48 days after the submission was received.
What is the product code of K932712?
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.