| K-number | K860693 |
| Device name | PULMANEX (TM) |
| Applicant | Life Design Systems, Inc. |
| Product code | BTM |
| Device class | Class II |
| Decision date | Mar 27, 1986 |
| Decision | Substantially Equivalent |
| Regulation | 868.5915 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov