The following data is part of a premarket notification filed by Adel Medical Ltd. with the FDA for Adel Medical Birthing Bed, #ld-500.
Device ID | K810886 |
510k Number | K810886 |
Device Name: | ADEL MEDICAL BIRTHING BED, #LD-500 |
Classification | Table, Obstetrical, Ac-powered (and Accessories) |
Applicant | ADEL MEDICAL LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HDD |
CFR Regulation Number | 884.4900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-04-01 |
Decision Date | 1981-04-23 |