Sniff Air Compressor #SF-6
FDA 510(k) K812767 · Timeter Instrument Corp.
510(k) numberK812767
Submission
- Device name
- Sniff Air Compressor #SF-6
- Applicant
- Timeter Instrument Corp.
Mchenry, IL, US - Received
- October 5, 1981
- Decision date
- November 27, 1981
- 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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|---|---|---|---|
| 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 |
|---|---|---|
| K875075 | RT-200 Computer InterfaceBXX · Traditional | 04/21/1988SE |
| K875074 | Vacumate Intermittent/Continuous CONTROLLER,VM2000KDP · Traditional | 02/22/1988SE |
| K871603 | Criterion II & Iia Oxygen ConcentratorsCAW · Traditional | 08/13/1987SE |
| K864836 | L.A.P. SpirometerBTY · Traditional | 03/06/1987SE |
| K834274 | Criterion ICAW · Traditional | 04/13/1984SE |
| K823775 | Bordon Gage Regulator #BgCCN · Traditional | 01/14/1983SE |
| K822746 | RT-200 Calibration AnalyzerBXX · Traditional | 10/13/1982SE |
| K812766 | PCS-5 AccessoriesBTI · Traditional | 12/17/1981SE |
| K813235 | Diss Female Air AdaptorBYK · Traditional | 12/08/1981SE |
| K813234 | Ohio Air AdaptorBYX · Traditional | 12/08/1981SE |
Questions and answers
When was Sniff Air Compressor #SF-6 cleared by the FDA?
Sniff Air Compressor #SF-6 (K812767) received a 510(k) decision of Substantially Equivalent on November 27, 1981, 53 days after the submission was received.
What is the product code of K812767?
The FDA product code is BTI – Compressor, Air, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.6250.