Humid-Vent 1 Port/Humid-Vent 1 Port Angle
FDA 510(k) K953491 · Gibeck, Inc.
510(k) numberK953491
Submission
- Device name
- Humid-Vent 1 Port/Humid-Vent 1 Port Angle
- Applicant
- Gibeck, Inc.
Indianapolis, IN, US - Received
- July 25, 1995
- Decision date
- August 25, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BYD – Condenser, Heat And Moisture (Artificial Nose)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5375
- Specialty
- Anesthesiology
Other 510(k)s with product code BYD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K955008 | Heat & Moisture ExchangerBYD · Traditional | Intertech Resources, Inc. | 01/30/1996SE |
| K954194 | Disposable Hme/FilterBYD · Traditional | Engstrom Medical | 10/20/1995SE |
| K953580 | Heat Moisture ExchangerBYD · Traditional | Intertech Resources, Inc. | 09/15/1995SE |
| K953507 | Type 1 & 2 (Humidair I & II)BYD · Traditional | Icor AB | 09/07/1995SE |
| K953620 | Warm N Wet Hmef W/Luer AdapterBYD · Traditional | Hospitak, Inc. | 08/25/1995SE |
| K953619 | Warm N Wet Hme W/Luer AdapterBYD · Traditional | Hospitak, Inc. | 08/25/1995SE |
| K953544 | Humid-Vent 2 Light/Humid-Vent 2 Port LightBYD · Traditional | Gibeck, Inc. | 08/25/1995SE |
| K953540 | EeeBYD · Traditional | Edentec Corp. | 08/25/1995SE |
| K952845 | Humid-Vent Trach-VentBYD · Traditional | Gibeck, Inc. | 07/25/1995SE |
| K952844 | Humid-Vent 2BYD · Traditional | Gibeck, Inc. | 07/20/1995SE |
More from Gibeck, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K965016 | Iso-Gard Filter ANGLED(18212)/ISO-GARD Filter STRAIGHT(19212)CAH · Traditional | 12/02/1997SE |
| K964377 | Thermal Regulation System BlanketDWJ · Traditional | 04/23/1997SE |
| K964382 | Humid-Vent Filter Compact Angled (18402)/HUMID-VENT Filter Compact STRAIGHT(19402)CAH · Traditional | 04/15/1997SE |
| K960511 | Gibeck Warmbag Reusable Convective Warming BlanketDWJ · Traditional | 01/13/1997SE |
| K954828 | Iso-Gard Hepa Filter-Hme, Iso-Ard Hepa Filter-Hme W/PortCAH · Traditional | 05/02/1996SE |
| K953544 | Humid-Vent 2 Light/Humid-Vent 2 Port LightBYD · Traditional | 08/25/1995SE |
| K952845 | Humid-Vent Trach-VentBYD · Traditional | 07/25/1995SE |
| K952844 | Humid-Vent 2BYD · Traditional | 07/20/1995SE |
| K952750 | Humid-Vent 1BYD · Traditional | 07/20/1995SE |
| K952084 | Humid-Vent Filter PediBYD · Traditional | 06/12/1995SE |
Questions and answers
When was Humid-Vent 1 Port/Humid-Vent 1 Port Angle cleared by the FDA?
Humid-Vent 1 Port/Humid-Vent 1 Port Angle (K953491) received a 510(k) decision of Substantially Equivalent on August 25, 1995, 31 days after the submission was received.
What is the product code of K953491?
The FDA product code is BYD – Condenser, Heat And Moisture (Artificial Nose), a Class I (low risk) device regulated under 21 CFR 868.5375.