The following data is part of a premarket notification filed by Adel Medical Ltd. with the FDA for Adel - Model 986 Infant Warmer.
| Device ID | K890476 |
| 510k Number | K890476 |
| Device Name: | ADEL - MODEL 986 INFANT WARMER |
| Classification | Incubator, Neonatal |
| Applicant | ADEL MEDICAL LTD. 16700 S.E. 120TH AVE. P.O. BOX 542 Clackamas, OR 97015 |
| Contact | Jackson Mcchord |
| Correspondent | Jackson Mcchord ADEL MEDICAL LTD. 16700 S.E. 120TH AVE. P.O. BOX 542 Clackamas, OR 97015 |
| Product Code | FMZ |
| CFR Regulation Number | 880.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-31 |
| Decision Date | 1989-06-16 |