Warm N Wet Hme W/Luer Adapter
FDA 510(k) K953619 · Hospitak, Inc.
510(k) numberK953619
Submission
- Device name
- Warm N Wet Hme W/Luer Adapter
- Applicant
- Hospitak, Inc.
Farmingdale, NY, US - Received
- August 3, 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 |
| K953544 | Humid-Vent 2 Light/Humid-Vent 2 Port LightBYD · Traditional | Gibeck, Inc. | 08/25/1995SE |
| K953540 | EeeBYD · Traditional | Edentec Corp. | 08/25/1995SE |
| K953491 | Humid-Vent 1 Port/Humid-Vent 1 Port AngleBYD · Traditional | Gibeck, Inc. | 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 |
|---|---|---|
| K955483 | Trach Mask Model (245, 246)BYF · Traditional | 02/28/1996SE |
| K954787 | IlluminatorCCW · Traditional | 01/31/1996SE |
| K953620 | Warm N Wet Hmef W/Luer AdapterBYD · Traditional | 08/25/1995SE |
| K915750 | Disposable Bacterial Breathng FilterCAH · Traditional | 11/30/1994SE |
| K920842 | Aerosol Delivery SystemsLRD · Traditional | 05/15/1992SE |
| K915228 | Disposable CO2 Gas Sampling/Oxygen Delivery CannulCCK · Traditional | 02/11/1992SE |
| K873286 | Disposable, Manual Pulmonary ResuscitatorBTM · Traditional | 10/26/1987SE |
| K853600 | Inflatable Air SplintsFZF · Traditional | 09/19/1985SE |
| K844328 | Oxygen ConcentratorCAW · Traditional | 12/04/1984SE |
| K843212 | Low Pressure Alarm for Oxygen CylinderBXH · Traditional | 09/19/1984SE |
Questions and answers
When was Warm N Wet Hme W/Luer Adapter cleared by the FDA?
Warm N Wet Hme W/Luer Adapter (K953619) received a 510(k) decision of Substantially Equivalent on August 25, 1995, 22 days after the submission was received.
What is the product code of K953619?
The FDA product code is BYD – Condenser, Heat And Moisture (Artificial Nose), a Class I (low risk) device regulated under 21 CFR 868.5375.