The following data is part of a premarket notification filed by J. T. Posey Co. with the FDA for Posey Bed.
Device ID | K113355 |
510k Number | K113355 |
Device Name: | POSEY BED |
Classification | Patient Bed With Canopy/restraints |
Applicant | J. T. POSEY CO. 5635 PECK RD. Arcadia, CA 91006 |
Contact | Bonnie Bishop |
Correspondent | Bonnie Bishop J. T. POSEY CO. 5635 PECK RD. Arcadia, CA 91006 |
Product Code | OYS |
CFR Regulation Number | 880.6760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-11-14 |
Decision Date | 2012-05-02 |
Summary: | summary |