Panels › Anesthesiology › Product code BTI · Class 2
Compressor, Air, Portable
Regulation 868.6250
0510(k)s in 12 months (74 all time)
0recalls in 12 months (5 all time)
2recalls that name a 510(k)
Top companies in BTI
| Company | 510(k)s | Recalls |
|---|---|---|
| Medical Industries America, Inc. | 4 | 0 |
| Timeter Instrument Corp. | 4 | 0 |
| Datex-Ohmeda, Inc. | 0 | 3 |
| Precision Medical, Inc. | 3 | 0 |
| Ashai Co. , Ltd. | 2 | 0 |
| Devilbiss Health Care, Inc. | 2 | 0 |
| Ekom S.R.O. | 2 | 0 |
| The John Bunn Co. | 2 | 0 |
| Mountain Medical Equipment, Inc. | 2 | 0 |
| Siemens Elema AB | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 30, 2024 | Datex-Ohmeda, Inc. EvAir CPRSR Kit Upgrade:
a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230849;
b) DISS/NEMA 5-15 115V 60 HZ, Model Number M1230847;
c) NIST/BS 1363 230V 50/60 HZ, Model Number M1230849;
d) NIST/B Open, Classified |
BTI | None listed |
| Jan 30, 2024 | Datex-Ohmeda, Inc. EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002 Open, Classified |
BTI | None listed |
| Jan 30, 2024 | Datex-Ohmeda, Inc. EVair air compressor, model numbers: M1230849 and M1230847 Open, Classified |
BTI | None listed |
| Jan 28, 2014 | Maquet Cardiovascular Us Sales, Llc Compressor Mini
To provide a supply of dry, filtered compressed air for a medical respiratory ventilator or anaesthesia machine that meet the specifications of the compressor mini. compressor mini is Terminated |
BTI | K023354 |
| Apr 5, 2007 | Draeger Medical, Inc. Medical Air Compressor
Model #8413419 Terminated |
BTI | K982789 |
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