Engineered Medical Systems · Class II · Cleared Jul 6, 1999
| K-number | K991955 |
| Device name | MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION |
| Applicant | Engineered Medical Systems |
| Product code | BTM |
| Device class | Class II |
| Decision date | Jul 6, 1999 |
| 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