The following data is part of a premarket notification filed by Medical Molding Corp. Of America with the FDA for Misty Ox Laminar Diffuser Humidifier.
| Device ID | K923754 |
| 510k Number | K923754 |
| Device Name: | MISTY OX LAMINAR DIFFUSER HUMIDIFIER |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | MEDICAL MOLDING CORP. OF AMERICA 240 BRIGGS AVE. Costa Mesa, CA 92626 -4555 |
| Contact | Terry Bagwell |
| Correspondent | Terry Bagwell MEDICAL MOLDING CORP. OF AMERICA 240 BRIGGS AVE. Costa Mesa, CA 92626 -4555 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-28 |
| Decision Date | 1992-12-07 |