The following data is part of a premarket notification filed by Intertech/ohio with the FDA for Pediatric Humidifier Tube W/ Temperature Port.
| Device ID | K884525 |
| 510k Number | K884525 |
| Device Name: | PEDIATRIC HUMIDIFIER TUBE W/ TEMPERATURE PORT |
| Classification | Set, Tubing And Support, Ventilator (w Harness) |
| 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 | BZO |
| CFR Regulation Number | 868.5975 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-27 |
| Decision Date | 1988-12-16 |