510(k) K925304
K925304 is an FDA 510(k) premarket notification submitted by Canon USA, Inc. for the device "AUTOREF LENSMETER RL-10". The FDA issued a decision of Substantially Equivalent on February 17, 1994. The device falls under product code HKO (Refractometer, Ophthalmic), a Class I device regulated under 21 CFR 886.1760. Canon USA, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 17, 1994
- Date Received
- October 21, 1992
- 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