The following data is part of a premarket notification filed by Surgi-med, Inc. with the FDA for Keane Mobility Bed.
Device ID | K873047 |
510k Number | K873047 |
Device Name: | KEANE MOBILITY BED |
Classification | Bed, Patient Rotation, Powered |
Applicant | SURGI-MED, INC. 815 TERMINAL RD. Lansing, MI 48906 |
Contact | Donald J Propp |
Correspondent | Donald J Propp SURGI-MED, INC. 815 TERMINAL RD. Lansing, MI 48906 |
Product Code | IKZ |
CFR Regulation Number | 890.5225 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-04 |
Decision Date | 1987-10-15 |