The following data is part of a premarket notification filed by Adel Medical Ltd. with the FDA for Labor/delivery/recovery Bed Ldr-600.
Device ID | K833321 |
510k Number | K833321 |
Device Name: | LABOR/DELIVERY/RECOVERY BED LDR-600 |
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 | 1983-09-26 |
Decision Date | 1983-11-14 |