The following data is part of a premarket notification filed by Adel Medical Ltd. with the FDA for Adel Model 2100 Birthing Bed.
Device ID | K874610 |
510k Number | K874610 |
Device Name: | ADEL MODEL 2100 BIRTHING BED |
Classification | Table, Obstetrical, Ac-powered (and Accessories) |
Applicant | ADEL MEDICAL LTD. 16700 S.E. 120TH AVE. P.O. BOX 542 Clackamas, OR 97015 |
Contact | Mcchord |
Correspondent | Mcchord ADEL MEDICAL LTD. 16700 S.E. 120TH AVE. P.O. BOX 542 Clackamas, OR 97015 |
Product Code | HDD |
CFR Regulation Number | 884.4900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-09 |
Decision Date | 1988-01-21 |