The following data is part of a premarket notification filed by Carroll Healthcare, Inc. with the FDA for Carroll Healthcare Dlx 2300-111 Electric Bed.
Device ID | K962250 |
510k Number | K962250 |
Device Name: | CARROLL HEALTHCARE DLX 2300-111 ELECTRIC BED |
Classification | Bed, Ac-powered Adjustable Hospital |
Applicant | CARROLL HEALTHCARE, INC. 110 TOWERLINE PLACE LONDON Ontario, CA |
Contact | Norm Kay |
Correspondent | Norm Kay CARROLL HEALTHCARE, INC. 110 TOWERLINE PLACE LONDON Ontario, CA |
Product Code | FNL |
CFR Regulation Number | 880.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-12 |
Decision Date | 1996-10-21 |