Aerosol One, Nebulizer Pump
FDA 510(k) K870428 · Ashai Co. , Ltd.
510(k) numberK870428
Submission
- Device name
- Aerosol One, Nebulizer Pump
- Applicant
- Ashai Co. , Ltd.
Australia, AU - Received
- February 3, 1987
- Decision date
- May 15, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BTI – Compressor, Air, Portable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.6250
- Specialty
- Anesthesiology
Other 510(k)s with product code BTI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K131881 | Ombra Table Top CompressorBTI · Traditional | Trudell Medical Intl. | 10/24/2013SE |
| K113338 | Medical Air CompressorBTI · Traditional | Oricare, Inc. | 08/10/2012SE |
| K091871 | DK50 DSBTI · Special | Ekom S.R.O. | 10/23/2009SE |
| K072634 | Emg Triton -Comp,Model NCA01-XXX SeriesBTI · Traditional | Emg Technology Co., Ltd. | 11/19/2008SE |
| K060781 | Medical Compressor, Models DK50 D and DMBTI · Traditional | Ekom S.R.O. | 10/03/2006SE |
| K051691 | Minimate CompressorBTI · Traditional | Precision Medical, Inc. | 12/09/2005SE |
| K041781 | Ventilair II Medical Air CompressorBTI · Traditional | Hamilton Medical AG | 03/14/2005SE |
| K041406 | Newport C250 Air Compressor Model C250BTI · Traditional | Newport Medical Instruments | 12/15/2004SE |
| K041974 | MED2000 Nebulizer Compressor, Models P3, P4, P5 with NebulizerBTI · Special | Med2000 S.R.L. | 08/24/2004SE |
| K040220 | Medical Air CompressorBTI · Traditional | eVent Medical, Ltd. | 06/09/2004SE |
More from eVent Medical, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K852622 | Aerosol OneBTI · Traditional | 04/24/1986SE |
| K852620 | Safe.N.SureHIS · Traditional | 10/31/1985SE |
| K852627 | Maxi-NebCCQ · Traditional | 09/26/1985SE |
| K852629 | Aero-Mask TwoBYG · Traditional | 09/18/1985SE |
| K852628 | Nasal OneCAT · Traditional | 09/18/1985SE |
| K852626 | Aero-Mask OneBYG · Traditional | 09/18/1985SE |
| K852625 | Oxy-TubeCAT · Traditional | 09/18/1985SE |
| K852624 | Oxy-TwoBYG · Traditional | 09/18/1985SE |
| K852623 | Oxy-OneBYG · Traditional | 09/18/1985SE |
| K852618 | Oxy-DialBYF · Traditional | 09/18/1985SE |
Questions and answers
When was Aerosol One, Nebulizer Pump cleared by the FDA?
Aerosol One, Nebulizer Pump (K870428) received a 510(k) decision of Substantially Equivalent on May 15, 1987, 101 days after the submission was received.
What is the product code of K870428?
The FDA product code is BTI – Compressor, Air, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.6250.