The following data is part of a premarket notification filed by Pulmodyne with the FDA for Pulmodyne Chf Flow Generator System.
| Device ID | K080256 |
| 510k Number | K080256 |
| Device Name: | PULMODYNE CHF FLOW GENERATOR SYSTEM |
| Classification | Attachment, Breathing, Positive End Expiratory Pressure |
| Applicant | PULMODYNE 24301 WOODSAGE DRIVE Bonita Springs, FL 33134 -2958 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden PULMODYNE 24301 WOODSAGE DRIVE Bonita Springs, FL 33134 -2958 |
| Product Code | BYE |
| CFR Regulation Number | 868.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-31 |
| Decision Date | 2008-05-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841470110540 | K080256 | 000 |
| 10841470109995 | K080256 | 000 |