510(k) K041974
- Device
- MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER
- Applicant
- MED2000 S.R.L.
- 510(k) number
- K041974
- Product code
- BTI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-08-24
- Date received
- 2004-07-22
- Regulation
- 868.6250
- Classification name
- Compressor, Air, Portable
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SUSAN D GOLDSTEIN-FALK
- Address
- 55 Northern Blvd., Suite 200 Great Neck NY US 11021 11021
FDA Registration Numbers#
- 3007549157
- 3017259276
- 3017886332
- 3005245901
- 3030447506
- 3013000203
- 3013345545
- 3008559238
- 3012316249
- 3029906224
- 8020893
- 3010493153
- 3018783526
- 9710567
- 3009129579
- 2031508
- 9612777
- 1316463
- 3000126629
- 3036830503
- 1000153536
- 3007740533
- 3022777869
- 3002797442
- 3043460907
- 3012336822
- 2515872
- 3014810929
- 2518422
- 3011716786
- 3015219192
- 3008830133
- 8022890
- 3003767629
- 3031700059
- 3022320321
- 3008078977
- 3007238566
- 3005569927
- 2523148
- 2951529
- 1039215
- 3018094310
- 3003803075
- 3006087789
- 2028807
- 3023272766
- 3013155768
- 3013496867
- 8010042
- 3017303999
- 3014624980
- 3044563261
- 3009683397
- 2024500
- 3006789357
- 1924066
- 3006157842
- 3003908598
- 9616843
- 3009834076
- 3008496560
- 3010287621
- 2112667
- 1317346
- 3015772781
- 3032013079
- 2954963
- 3014766741
Source Documents#
Other 510(k) Records For Product Code BTI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K131881 | OMBRA TABLE TOP COMPRESSOR | Trudell Medical Intl. | 2013-10-24 |
| K113338 | MEDICAL AIR COMPRESSOR | Oricare, Inc. | 2012-08-10 |
| K091871 | DK50 DS | Ekom S.R.O. | 2009-10-23 |
| K072634 | EMG TRITON -COMP,MODEL NCA01-XXX SERIES | Emg Technology Co., Ltd. | 2008-11-19 |
| K060781 | MEDICAL COMPRESSOR, MODELS DK50 D AND DM | Ekom S.R.O. | 2006-10-03 |
| K051691 | MINIMATE COMPRESSOR | Precision Medical, Inc. | 2005-12-09 |
| K041781 | VENTILAIR II MEDICAL AIR COMPRESSOR | Hamilton Medical AG | 2005-03-14 |
| K041406 | NEWPORT C250 AIR COMPRESSOR MODEL C250 | Newport Medical Instruments | 2004-12-15 |
| K040220 | MEDICAL AIR COMPRESSOR | eVent Medical, Ltd. | 2004-06-09 |
| K031686 | AEROMIST LT, MODEL HCS15004 | Medline Industries, Inc. | 2004-01-21 |
| K031413 | VIGORMIST COMPRESSOR NEBULIZER | Vega Technologies, Inc. | 2003-10-07 |
| K023354 | COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E | Siemens Elema AB | 2003-09-05 |
| K020797 | PULMO-MIST COMPRESSOR MODEL # 4323 | Nidek Medical Products, Inc. | 2002-05-03 |
| K013027 | MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123 | Respironics Healthscan, Inc. | 2001-12-06 |
| K002862 | PRONEB ULTRA MODEL NUMBER 85B0100 | Pari Holding Co. | 2001-03-13 |
Legacy Summary#
summary
FDA Review#
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