Siemens-Elema A.B. Servo Humidifier 150
FDA 510(k) K790681 · Siemens Corp.
510(k) numberK790681
Submission
- Device name
- Siemens-Elema A.B. Servo Humidifier 150
- Applicant
- Siemens Corp.
Mchenry, IL, US - Received
- April 10, 1979
- Decision date
- April 13, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
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Questions and answers
When was Siemens-Elema A.B. Servo Humidifier 150 cleared by the FDA?
Siemens-Elema A.B. Servo Humidifier 150 (K790681) received a 510(k) decision of Substantially Equivalent on April 13, 1979, 3 days after the submission was received.
What is the product code of K790681?
The FDA product code is BYD – Condenser, Heat And Moisture (Artificial Nose), a Class I (low risk) device regulated under 21 CFR 868.5375.