Continuous Ventilator
FDA 510(k) K844809 · Hamilton Medical, Inc.
510(k) numberK844809
Submission
- Device name
- Continuous Ventilator
- Applicant
- Hamilton Medical, Inc.
Reno, NV, US - Received
- December 27, 1984
- Decision date
- June 27, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GBX – Catheter, Irrigation
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GBX
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|---|---|---|---|
| K131659 | Moerae Vein Preparation KitGBX · Traditional | Moerae Matrix, Inc. | 03/03/2014SE |
| K082725 | Graftguard Pressure Controlling SyringeGBX · Traditional | Maquet Cardiovascular, LLC | 12/17/2008SE |
| K052286 | Deutsch Anti-Blockage Wound DrainGBX · Traditional | The Catheter Exchange, Inc. | 10/21/2005SE |
| K043515 | GraftsaverGBX · Traditional | Vescare, Inc. | 03/31/2005SE |
| K013417 | Misonix Irrigation System Moedl BC20PGBX · Traditional | Misonix, Inc. | 01/10/2002SE |
| K000704 | DMC Saphenous Vein Distention System (SVDS)GBX · Traditional | Dmc Medical, Ltd. | 05/19/2000SE |
| K974233 | Lysonix Irrigation SystemGBX · Traditional | Lysonix, Inc. | 02/03/1998SE |
| K973703 | Jackson-Pratt Hemaduct Wound Drain, Jackson-Pratt Gold Hemaduct Wound DrainGBX · Traditional | Allegiance Healthcare Corp. | 12/04/1997SE |
| K972635 | Ultracell Suction SpongeGBX · Traditional | Ultracell Medical Technologies, Inc. | 10/01/1997SE |
| K965146 | Flat Closed Wound Drain with TrocarGBX · Traditional | Axiom Medical, Inc. | 03/10/1997SE |
More from Axiom Medical, 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 Continuous Ventilator cleared by the FDA?
Continuous Ventilator (K844809) received a 510(k) decision of Substantially Equivalent on June 27, 1985, 182 days after the submission was received.
What is the product code of K844809?
The FDA product code is GBX – Catheter, Irrigation, a Class I (low risk) device regulated under 21 CFR 878.4200.