The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Ohmeda Infant Resuscitation System.
| Device ID | K971243 |
| 510k Number | K971243 |
| Device Name: | OHMEDA INFANT RESUSCITATION SYSTEM |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | OHMEDA MEDICAL 9065 GUILFORD RD. Columbia, MD 21046 |
| Contact | Alberto F Profumo |
| Correspondent | Alberto F Profumo OHMEDA MEDICAL 9065 GUILFORD RD. Columbia, MD 21046 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-03 |
| Decision Date | 1997-12-02 |
| Summary: | summary |