510(k) K940516
K940516 is an FDA 510(k) premarket notification submitted by Canon, Inc. for the device "AUTO REFF-30". The FDA issued a decision of Substantially Equivalent on July 12, 1994. The device falls under product code HKO (Refractometer, Ophthalmic), a Class I device regulated under 21 CFR 886.1760. Canon, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 12, 1994
- Date Received
- February 4, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Refractometer, Ophthalmic
- Device Class
- Class I
- Regulation Number
- 886.1760
- Review Panel
- OP
- Submission Type