The following data is part of a premarket notification filed by Intertech/ohio with the FDA for Adult Resuscitator With Mask And Filter.
| Device ID | K884526 |
| 510k Number | K884526 |
| Device Name: | ADULT RESUSCITATOR WITH MASK AND FILTER |
| 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 | 1988-10-27 |
| Decision Date | 1988-11-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10351688400512 | K884526 | 000 |