The following data is part of a premarket notification filed by Intertech/ohio with the FDA for First Response Pediatric Emergency Resuscitator.
| Device ID | K880394 |
| 510k Number | K880394 |
| Device Name: | FIRST RESPONSE PEDIATRIC EMERGENCY RESUSCITATOR |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | INTERTECH/OHIO 5030 TICE ST. Fort Myers, FL 33905 |
| Contact | James W Pope |
| Correspondent | James W Pope INTERTECH/OHIO 5030 TICE ST. Fort Myers, FL 33905 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-29 |
| Decision Date | 1988-02-29 |