Econo-Mist Portable Compressor Driven Nebulizer
FDA 510(k) K873677 · Mountain Medical Equipment, Inc.
510(k) numberK873677
Submission
- Device name
- Econo-Mist Portable Compressor Driven Nebulizer
- Applicant
- Mountain Medical Equipment, Inc.
Littleton, CO, US - Received
- September 14, 1987
- Decision date
- October 20, 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
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| 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 |
|---|---|---|
| K941793 | Oxygen Concentration Status Indicator (O.C.S.I.)CCL · Traditional | 06/21/1995SE |
| K923650 | ScottyCAW · Traditional | 01/15/1993SE |
| K924684 | MicroflowCAF · Traditional | 12/15/1992SE |
| K914916 | Alpine VCAW · Traditional | 09/23/1992SE |
| K902890 | Aspen 3 Oxygen ConcentratorCAW · Traditional | 07/19/1990SE |
| K893531 | Cuff SpeculumKPL · Traditional | 06/22/1989SE |
| K884084 | Portable Oxygen GeneratorCAW · Traditional | 11/21/1988SE |
| K881802 | Alpine Portable Oxygen GeneratorCAW · Traditional | 07/08/1988SE |
| K873170 | AriesBYE · Traditional | 09/25/1987SE |
| K864005 | AlpineCAW · Traditional | 01/28/1987SE |
Questions and answers
When was Econo-Mist Portable Compressor Driven Nebulizer cleared by the FDA?
Econo-Mist Portable Compressor Driven Nebulizer (K873677) received a 510(k) decision of Substantially Equivalent on October 20, 1987, 36 days after the submission was received.
What is the product code of K873677?
The FDA product code is BTI – Compressor, Air, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.6250.