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510(k) K862034

JEDMED CCD-02 VIDEO CAMERA SYSTEM by Jedmed Instrument Co. — Product Code FWD

K862034 is an FDA 510(k) premarket notification submitted by Jedmed Instrument Co. for the device "JEDMED CCD-02 VIDEO CAMERA SYSTEM". The FDA issued a decision of Substantially Equivalent on June 9, 1986. 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 9, 1986
Date Received
May 29, 1986
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

Other clearances by Jedmed Instrument Co.

  • K150248 — ORL Video NasoPharyngo-Larngoscope (July 23, 2015)
  • K132039 — ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM (February 21, 2014)
  • K021750 — LID CHAIN EYELID WEIGHTS (January 27, 2003)
  • K954184 — JED-LIGHT FIBEROPTIC LIGHT SOURCE (November 13, 1995)
  • K944032 — VIDEO SCOPE SYSTEM (LARYNGOSCOPE) (September 15, 1995)
  • K953457 — JEDMED SPECTRUM ENT CABINET (August 11, 1995)
  • K950925 — JEDMED LARYNGEAL SCOPE (August 11, 1995)
  • K950785 — HORTMANN AIRMATIC AIR CALORIC STIMULATOR (June 28, 1995)
  • K950078 — MICROFLOW IRRIGATION SYSTEM (June 21, 1995)
  • K944671 — VIDEO SCOPE SYSTEM (NASOPHARYNGOSCOPE {FLEXIBLE OR RIGID}) (February 7, 1995)

Other clearances for product code FWD

  • K891236 — FDX SOLID STATE VIDEO CAMERA MODEL 5950 (April 5, 1989)
  • K882166 — JEDMED MICRO CCD CAMERA SYSTEM (June 15, 1988)
  • K862664 — JEDMED CCD CAMERA SYSTEM (July 30, 1986)
  • K862145 — JEDMED MINI-MOS VIDEO CAMERA (June 13, 1986)

FDA data resources