The following data is part of a premarket notification filed by Adel Medical Ltd. with the FDA for Adel Medical Birthing Bed, Mod. Ld-400.
| Device ID | K801622 |
| 510k Number | K801622 |
| Device Name: | ADEL MEDICAL BIRTHING BED, MOD. LD-400 |
| Classification | Table, Obstetric (and Accessories) |
| Applicant | ADEL MEDICAL LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KNC |
| CFR Regulation Number | 884.4900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-15 |
| Decision Date | 1980-08-14 |