510(k) K882166
K882166 is an FDA 510(k) premarket notification submitted by Jedmed Instrument Co. for the device "JEDMED MICRO CCD CAMERA SYSTEM". The FDA issued a decision of Substantially Equivalent on June 15, 1988. The device falls under product code FWD (Camera, Television, Microsurgical, Without Audio), a Class I device regulated under 21 CFR 878.4160. Jedmed Instrument Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 15, 1988
- Date Received
- May 24, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Television, Microsurgical, Without Audio
- Device Class
- Class I
- Regulation Number
- 878.4160
- Review Panel
- SU
- Submission Type