The following data is part of a premarket notification filed by Aeiomed, Inc. with the FDA for Model 300157 Cpap System.
| Device ID | K100121 |
| 510k Number | K100121 |
| Device Name: | MODEL 300157 CPAP SYSTEM |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | AEIOMED, INC. 1313 5TH STREET SE, STE 205 Minneapolis, MN 55414 |
| Contact | Darin Busch |
| Correspondent | Darin Busch AEIOMED, INC. 1313 5TH STREET SE, STE 205 Minneapolis, MN 55414 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-15 |
| Decision Date | 2010-07-13 |
| Summary: | summary |