Ultra-Neb 99 Ultrasonic Nebulizer
FDA 510(k) K872826 · The Devilbiss Co.
510(k) numberK872826
Submission
- Device name
- Ultra-Neb 99 Ultrasonic Nebulizer
- Applicant
- The Devilbiss Co.
Somerset, PA, US - Received
- July 16, 1987
- Decision date
- September 4, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CAF – Nebulizer (Direct Patient Interface)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5630
- Specialty
- Anesthesiology
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| K232507 | Aerogen®Solo Nebulizer SystemCAF · Traditional | Aerogen, Ltd. | 05/10/2024SE |
More from Aerogen, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K874041 | Devilbiss Model 8500DCAF · Traditional | 12/23/1987SE |
| K872094 | Vacu-AideJCX · Traditional | 10/15/1987SE |
| K872470 | DEVO/MC44 Oxygen ConcentratorCAW · Traditional | 08/03/1987SE |
| K854520 | Pulmo-Aide Model 5610DCCQ · Traditional | 12/09/1985SE |
| K852209 | DEVO/MC29 Oxygen Concentrator MC29DCAW · Traditional | 06/24/1985SE |
| K851695 | Ultra-Neb 100 Ultrasonic Nebulizer · Traditional | 06/05/1985SE |
| K830174 | De VO/44 Oxygen Concentrator #444CAW · Traditional | 02/17/1983SE |
| K801526 | Surveyor I, Respiratory Computer SystemBZC · Traditional | 07/21/1980SE |
| K792385 | Devo Oxygen Concentrator, Model 955CAW · Traditional | 12/05/1979SE |
| K781073 | Pulmo-SonicCCQ · Traditional | 09/27/1978SE |
Questions and answers
When was Ultra-Neb 99 Ultrasonic Nebulizer cleared by the FDA?
Ultra-Neb 99 Ultrasonic Nebulizer (K872826) received a 510(k) decision of Substantially Equivalent on September 4, 1987, 50 days after the submission was received.
What is the product code of K872826?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.