Compressor
FDA 510(k) K792457 · Pneupac , Ltd.
510(k) numberK792457
Submission
- Device name
- Compressor
- Applicant
- Pneupac , Ltd.
Mchenry, IL, US - Received
- December 3, 1979
- Decision date
- February 5, 1980
- 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 |
|---|---|---|
| K040090 | Comppac 200HD; CS12 Power Supply (Aircraft/Vechile); PS11 Power Supply (Mains)BTL · Traditional | 05/27/2004SE |
| K030803 | Parapac 200D Transport, Model V200DBTL · Traditional | 09/29/2003SE |
| K021841 | Comppac Ventilator Models 200 & PS11 Power Supply/ChargerBTL · Traditional | 07/17/2003SE |
| K020899 | Parapac 200 Medic, Model P200, & Parapac 200D Medic, Model P200DBTL · Traditional | 12/13/2002SE |
| K970158 | BabypacCBK · Traditional | 04/28/1998SE |
| K960515 | ParapacBTL · Traditional | 10/10/1996SE |
| K863410 | Patient Valve with Air EntrainmentBTL · Traditional | 01/12/1987SE |
| K862830 | Models 2R and 3R Pneupac Ventilator/ResuscitatorBTL · Traditional | 10/15/1986SE |
| K843737 | Pneupac Instant Action Ventilator/ResusCBK · Traditional | 10/04/1984SE |
| K832700 | Pneu Pac Ventilator/ResuscitatorsCBK · Traditional | 11/14/1983SE |
Questions and answers
When was Compressor cleared by the FDA?
Compressor (K792457) received a 510(k) decision of Substantially Equivalent on February 5, 1980, 64 days after the submission was received.
What is the product code of K792457?
The FDA product code is BTI – Compressor, Air, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.6250.