510(k) K001111
K001111 is an FDA 510(k) premarket notification submitted by Cmt Medical Technologies, Ltd. for the device "PANORET, MODEL 1000A". The FDA issued a decision of Substantially Equivalent on July 7, 2000. The device falls under product code HKL (Retinoscope, Ac-Powered), a Class II device regulated under 21 CFR 886.1780. Cmt Medical Technologies, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 7, 2000
- Date Received
- April 6, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Retinoscope, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.1780
- Review Panel
- OP
- Submission Type