DK50 DS
FDA 510(k) clearance K091871 · decided 2009-10-23
Clearance details
- K-number
- K091871
- Device name
- DK50 DS
- Applicant
- Ekom S.R.O.
- Decision
- Substantially Equivalent
- Date received
- 2009-06-23
- Decision date
- 2009-10-23
- Days to decision
- 122 days
- Clearance type
- Special
- Product code
- BTI
- Device class
- 2
- Regulation number
- 868.6250
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Bonita Springs, FL, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| MEDICAL AIR COMPRESSOR (K113338) | Oricare, Inc. | 2012-08-10 |
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| MINIMATE COMPRESSOR (K051691) | Precision Medical, Inc. | 2005-12-09 |
| VENTILAIR II MEDICAL AIR COMPRESSOR (K041781) | Hamilton Medical AG | 2005-03-14 |
| NEWPORT C250 AIR COMPRESSOR MODEL C250 (K041406) | Newport Medical Instruments | 2004-12-15 |
| MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER (K041974) | Med2000 S.R.L. | 2004-08-24 |
| MEDICAL AIR COMPRESSOR (K040220) | eVent Medical, Ltd. | 2004-06-09 |
| AEROMIST LT, MODEL HCS15004 (K031686) | Medline Industries, Inc. | 2004-01-21 |
| VIGORMIST COMPRESSOR NEBULIZER (K031413) | Vega Technologies, Inc. | 2003-10-07 |
| COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E (K023354) | Siemens Elema AB | 2003-09-05 |
Recalls involving this device
No recalls on record reference this clearance.