510(k) K900161
K900161 is an FDA 510(k) premarket notification submitted by Jedmed Instrument Co. for the device "A-SCAN ROLL-AROUND STAND". The FDA issued a decision of Substantially Equivalent on February 16, 1990. The device falls under product code HMG (Stand, Instrument, Ophthalmic, Non-Powered), a Class I device regulated under 21 CFR 886.1860. Jedmed Instrument Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 16, 1990
- Date Received
- January 12, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stand, Instrument, Ophthalmic, Non-Powered
- Device Class
- Class I
- Regulation Number
- 886.1860
- Review Panel
- OP
- Submission Type