The following data is part of a premarket notification filed by Promedic, Inc. with the FDA for Datex Engstom Manual Resuscitator.
| Device ID | K970991 |
| 510k Number | K970991 |
| Device Name: | DATEX ENGSTOM MANUAL RESUSCITATOR |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | PROMEDIC, INC. 6329 WEST WATERVIEW CT. Mccordsville, IN 46055 -9501 |
| Contact | Paul E Dryden |
| Correspondent | Paul E Dryden PROMEDIC, INC. 6329 WEST WATERVIEW CT. Mccordsville, IN 46055 -9501 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-19 |
| Decision Date | 1997-06-16 |
| Summary: | summary |