Sims Portex, Inc. · Class II · Cleared Sep 13, 1999
| K-number | K992057 |
| Device name | IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006 |
| Applicant | Sims Portex, Inc. |
| Product code | BTM |
| Device class | Class II |
| Decision date | Sep 13, 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