Prima Breathing Bags
FDA 510(k) K952011 · Prima, Inc.
510(k) numberK952011
Submission
- Device name
- Prima Breathing Bags
- Applicant
- Prima, Inc.
Cleveland, TN, US - Received
- April 28, 1995
- Decision date
- May 22, 1995
- 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 |
| 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 |
| K935582 | Tube, Inhaler OxygenBZO · Traditional | Puritas Health Care, Inc. | 01/14/1994SE |
More from Puritas Health Care, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K952022 | Prima Volumn VentilatorssBZO · Traditional | 05/22/1995SE |
| K952021 | Prima Hyuperinflation SystemBZR · Traditional | 05/22/1995SE |
| K952020 | Prima Pediatric Anesthesia CircuitsCAI · Traditional | 05/22/1995SE |
| K952019 | Prima Adult Gas Sampling CircuitsCAI · Traditional | 05/22/1995SE |
| K952018 | Prima Coaxial CircuitsCAI · Traditional | 05/22/1995SE |
| K952017 | Prima Mapleson D CircuitCAI · Traditional | 05/22/1995SE |
| K952016 | Prima Pediatric Gas Sampling CircuitsCAI · Traditional | 05/22/1995SE |
| K952015 | Prima FilterCAH · Traditional | 05/22/1995SE |
| K952014 | Prima Adult Temperature Monitoring Anesthesia CircuitsCAI · Traditional | 05/22/1995SE |
| K952013 | Prima Guedel AirwaysBTR · Traditional | 05/22/1995SE |
Questions and answers
When was Prima Breathing Bags cleared by the FDA?
Prima Breathing Bags (K952011) received a 510(k) decision of Substantially Equivalent on May 22, 1995, 24 days after the submission was received.
What is the product code of K952011?
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.