The following data is part of a premarket notification filed by Hill-rom Co. with the FDA for Procedural Strecher With Intellidrive P8000.
Device ID | K112502 |
510k Number | K112502 |
Device Name: | PROCEDURAL STRECHER WITH INTELLIDRIVE P8000 |
Classification | Stretcher, Wheeled, Powered |
Applicant | HILL-ROM CO. 1069 STATE RT. 46 EAST Batesville, IN 47006 -9167 |
Contact | Chad Hodson |
Correspondent | Paula Wilkerson INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
Product Code | INK |
CFR Regulation Number | 890.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2011-08-30 |
Decision Date | 2011-09-19 |
Summary: | summary |