The following data is part of a premarket notification filed by Intertech/ohio with the FDA for Resuscitator Valve Assembly W/filter.
| Device ID | K882204 |
| 510k Number | K882204 |
| Device Name: | RESUSCITATOR VALVE ASSEMBLY W/FILTER |
| Classification | Valve, Non-rebreathing |
| 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 | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-25 |
| Decision Date | 1988-07-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10351688413215 | K882204 | 000 |