Duns Number:654386890
Device Description: ACP-1500 Auto projectorACP-1500 Auto projector adopts new optical bench and helical focusi ACP-1500 Auto projectorACP-1500 Auto projector adopts new optical bench and helical focusing, more convenient to operate and image sharpness more clear and easier to adjust .Changed to electric control, chart switch speed is improved to 30% faster than ACP-1000, with locating faster, more precise and less dithering.Upgraded optical bench, solving the problem of fogging and dust gathering under long-hour workingNew design for ACP-1500, modern and fashinable.
Catalog Number
-
Brand Name
Auto chart projector
Version/Model Number
ACP-1500
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HOS
Product Code Name
Projector, Ophthalmic
Public Device Record Key
b140a120-e4c1-440a-9825-c21ce23b0136
Public Version Date
August 13, 2020
Public Version Number
1
DI Record Publish Date
August 05, 2020
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 | 15 |