510(k) K860174
K860174 is an FDA 510(k) premarket notification submitted by Chromagraphics, Inc. for the device "GUNKEL CHROMAGRAPH COLOR VISION TESTER". The FDA issued a decision of Substantially Equivalent on April 4, 1986. The device falls under product code HIW (Anomaloscope), a Class I device regulated under 21 CFR 886.1070.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 4, 1986
- Date Received
- January 17, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Anomaloscope
- Device Class
- Class I
- Regulation Number
- 886.1070
- Review Panel
- OP
- Submission Type