The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Omron Compressor Systems, Models Ne-c28,ne-c30.
| Device ID | K060811 |
| 510k Number | K060811 |
| Device Name: | OMRON COMPRESSOR SYSTEMS, MODELS NE-C28,NE-C30 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | OMRON HEALTHCARE, INC. 6329 W. WATERVIEW CT. Mccordsville, IN 46055 -9501 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden OMRON HEALTHCARE, INC. 6329 W. WATERVIEW CT. Mccordsville, IN 46055 -9501 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-24 |
| Decision Date | 2006-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00073796453305 | K060811 | 000 |
| 00073796391508 | K060811 | 000 |
| 00073796391102 | K060811 | 000 |
| 00073796391003 | K060811 | 000 |
| 00073796390006 | K060811 | 000 |
| 00073796330620 | K060811 | 000 |
| 00073796330132 | K060811 | 000 |
| 00073796328627 | K060811 | 000 |