The following data is part of a premarket notification filed by Inspired Technologies, Inc. with the FDA for Clinical Oxygen Dose Recorder (codr), Model 300-cr.
| Device ID | K082853 |
| 510k Number | K082853 |
| Device Name: | CLINICAL OXYGEN DOSE RECORDER (CODR), MODEL 300-CR |
| Classification | Ventilatory Effort Recorder |
| Applicant | INSPIRED TECHNOLOGIES, INC. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 -2958 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden INSPIRED TECHNOLOGIES, INC. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 -2958 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-29 |
| Decision Date | 2009-03-23 |
| Summary: | summary |