Sims Portex, Inc. · Class II · Cleared Jan 18, 2000
| K-number | K991861 |
| Device name | 1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE |
| Applicant | Sims Portex, Inc. |
| Product code | BTM |
| Device class | Class II |
| Decision date | Jan 18, 2000 |
| Decision | Substantially Equivalent |
| Regulation | 868.5915 |
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