The following data is part of a premarket notification filed by Mallinckrodt Medical with the FDA for Hygrolife.
| Device ID | K942794 |
| 510k Number | K942794 |
| Device Name: | HYGROLIFE |
| Classification | Condenser, Heat And Moisture (artificial Nose) |
| Applicant | MALLINCKRODT MEDICAL R.D. #1 BOX 1173 HOOK ROAD Argyle, NY 12809 |
| Contact | James C Webber |
| Correspondent | James C Webber MALLINCKRODT MEDICAL R.D. #1 BOX 1173 HOOK ROAD Argyle, NY 12809 |
| Product Code | BYD |
| CFR Regulation Number | 868.5375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-14 |
| Decision Date | 1994-08-22 |