The following data is part of a premarket notification filed by International Respiratory Systems, Inc. with the FDA for International Respiratory Systems, Inc.'s Manual Resusciator.
| Device ID | K981307 |
| 510k Number | K981307 |
| Device Name: | INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL RESUSCIATOR |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | INTERNATIONAL RESPIRATORY SYSTEMS, INC. PO BOX 4341 Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith INTERNATIONAL RESPIRATORY SYSTEMS, INC. PO BOX 4341 Crofton, MD 21114 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-10 |
| Decision Date | 1998-07-06 |