Duns Number:037304144
Device Description: Remote Control Operating Room Table With Radiographic Top Hi-Low (26" To 48") Longitudina Remote Control Operating Room Table With Radiographic Top Hi-Low (26" To 48") Longitudinal Slide (12 9/16) Trendelenburg 30 Degrees Reverse Trendelenburg 30 Degrees Side Tilt 20 Degrees Right To Left Back Section Up 90 Degrees 50 Degrees Down Reverse Orientation 80 Degrees Up 105 Degrees Down Flex Back Down 20 Degrees Maximum With Seat Down 25 Degrees Reflex Back Up 25 Degrees Return To Level Built-In Battery Back-Up Back Lit Hand Control 1000Lbs Weight Capacity. Patient Surface Is 77 3/4" L X 20 3/4" W. Overall Size Is 79" L X 23" W. Electrical Specification Ac 110/120V/5A 300W. 50/60 Hz. Current Leakage . <100 Microamps.
Catalog Number
FHC1000S
Brand Name
FHC 1000S Radiographic Top O.R. Table W/Slide
Version/Model Number
FHC1000KS.1v03.1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FQO
Product Code Name
Table, Operating-Room, Ac-Powered
Public Device Record Key
6d93eefc-1aa3-4379-8bdb-801272dd7aef
Public Version Date
December 10, 2018
Public Version Number
1
DI Record Publish Date
November 08, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 287 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |