The following data is part of a premarket notification filed by Sensormedics Corp. with the FDA for Infant Flow Ncpap Masks.
| Device ID | K984254 |
| 510k Number | K984254 |
| Device Name: | INFANT FLOW NCPAP MASKS |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | SENSORMEDICS CORP. 22705 SAVI RANCH PKWY. Yorba Linda, CA 92887 -4645 |
| Contact | Paul L Kittinger |
| Correspondent | Paul L Kittinger SENSORMEDICS CORP. 22705 SAVI RANCH PKWY. Yorba Linda, CA 92887 -4645 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-27 |
| Decision Date | 1999-02-24 |
| Summary: | summary |