The following data is part of a premarket notification filed by Intertech Resources, Inc. with the FDA for Inspiron(r) Breath For Life Emerg. Resuscitator.
| Device ID | K870253 |
| 510k Number | K870253 |
| Device Name: | INSPIRON(R) BREATH FOR LIFE EMERG. RESUSCITATOR |
| Classification | Valve, Non-rebreathing |
| Applicant | INTERTECH RESOURCES, INC. 5100 TICE ST. Ft. Myers, FL 33905 |
| Contact | James W Pope |
| Correspondent | James W Pope INTERTECH RESOURCES, INC. 5100 TICE ST. Ft. Myers, FL 33905 |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-22 |
| Decision Date | 1987-03-06 |