Pulmo-Mist Compressor Model # 4323
FDA 510(k) K020797 · Nidek Medical Products, Inc.
510(k) numberK020797
Submission
- Device name
- Pulmo-Mist Compressor Model # 4323
- Applicant
- Nidek Medical Products, Inc.
Birmingham, AL, US - Received
- March 12, 2002
- Decision date
- May 3, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 |
|---|---|---|
| K192693 | Nuvo Nano Portable Oxygen ConcentratorCAW · Traditional | 05/07/2020SE |
| K123738 | Mark 5 Nuvo Lite Ocsi, Mark 5 Nuvo Lite STDCAW · Special | 02/28/2013SE |
| K093308 | Mark 5 Nuvo 8 Ocsi, Mark 5 Nuvo 8 STDCAW · Special | 01/14/2010SE |
| K082566 | Mark 5 Nuvo Lite Ocsi and STDCAW · Abbreviated | 12/03/2008SE |
| K040892 | Mark 5 Nuvo Ocsi (M5C5), Models 505 and 905CAW · Special | 04/29/2004SE |
| K032509 | Mark 5 Nuvo (M5C5)CAW · Traditional | 03/18/2004SE |
| K980551 | Silenzio Delta Continuous Positive Airway Pressure SystemBZD · Traditional | 11/17/1998SE |
| K962492 | Silenzio Plus Continuous Positive Airway Pressure SystemBYE · Traditional | 01/23/1997SE |
| K952966 | CP-90 Continuous Positive Airway Pressure SystemBZD · Traditional | 05/07/1996SE |
| K942593 | Oxychek Oxygen AnalyzerCCL · Traditional | 05/03/1995SE |
Questions and answers
When was Pulmo-Mist Compressor Model # 4323 cleared by the FDA?
Pulmo-Mist Compressor Model # 4323 (K020797) received a 510(k) decision of Substantially Equivalent on May 3, 2002, 52 days after the submission was received.
What is the product code of K020797?
The FDA product code is BTI – Compressor, Air, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.6250.