Infant Flow System
FDA 510(k) K945740 · Hamilton Medical, Inc.
510(k) numberK945740
Submission
- Device name
- Infant Flow System
- Applicant
- Hamilton Medical, Inc.
Reno, NV, US - Received
- November 23, 1994
- Decision date
- March 23, 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 |
| K952011 | Prima Breathing BagsBZO · Traditional | Prima, Inc. | 05/22/1995SE |
| K952010 | Prima Ventilator HosesBZO · Traditional | Prima, Inc. | 05/22/1995SE |
| 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 |
|---|---|---|
| K201306 | HAMILTON-C3CBK · Traditional | 02/05/2021SE |
| K201658 | Hamilton-C6CBK · Traditional | 12/11/2020SE |
| K193228 | Hamilton-G5CBK · Traditional | 05/04/2020SE |
| K181216 | HAMILTON-T1, HAMILTON-C1CBK · Traditional | 08/02/2019SE |
| K163283 | HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010BTT · Traditional | 09/20/2017SE |
| K161450 | HAMILTON-C3CBK · Traditional | 04/27/2017SE |
| K153046 | HAMILTON-MR1CBK · Traditional | 09/06/2016SE |
| K152029 | HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010BTT · Traditional | 05/03/2016SE |
| K150893 | IntelliCuffBSK · Traditional | 01/29/2016SE |
| K140939 | HAMILTON-T1,HAMILTON-C1CBK · Traditional | 09/02/2015SE |
Questions and answers
When was Infant Flow System cleared by the FDA?
Infant Flow System (K945740) received a 510(k) decision of Substantially Equivalent on March 23, 1995, 120 days after the submission was received.
What is the product code of K945740?
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.