510(k) K841293
K841293 is an FDA 510(k) premarket notification submitted by Keller Instruments, Inc. for the device "PANORAMIC LOUPES - VARIOUS". The FDA issued a decision of Substantially Equivalent on May 9, 1984. The device falls under product code HLT (Preamplifier, Ac-Powered, Ophthalmic), a Class II device regulated under 21 CFR 886.1640. Keller Instruments, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 9, 1984
- Date Received
- March 29, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Preamplifier, Ac-Powered, Ophthalmic
- Device Class
- Class II
- Regulation Number
- 886.1640
- Review Panel
- OP
- Submission Type