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510(k) K953457

JEDMED SPECTRUM ENT CABINET by Jedmed Instrument Co. — Product Code ETF

K953457 is an FDA 510(k) premarket notification submitted by Jedmed Instrument Co. for the device "JEDMED SPECTRUM ENT CABINET". The FDA issued a decision of Substantially Equivalent on August 11, 1995. The device falls under product code ETF (Unit, Examining/Treatment, Ent), a Class I device regulated under 21 CFR 874.5300. Jedmed Instrument Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1995
Date Received
July 21, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Examining/Treatment, Ent
Device Class
Class I
Regulation Number
874.5300
Review Panel
EN
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)
  • 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)
  • K944031 — VIDEO SCOPE SYSTEM (OTOSCOPE) (September 23, 1994)

Other clearances for product code ETF

  • K945395 — PREMIER MIRROR WARMER (January 18, 1995)
  • K932470 — LANGGASSE 90 (August 25, 1993)
  • K911901 — MAXI CABINET OPTIONAL BUILT IN S6000 LIGHT SOURCE (July 26, 1991)
  • K910781 — #491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCES (May 15, 1991)
  • K910243 — MOBILE TREATMENT CART (April 17, 1991)
  • K896298 — JEDMED S CHAIR (January 26, 1990)
  • K896273 — SYSTEMA ENT CABINET (January 26, 1990)
  • K881958 — JEDMED MAXIM ENT CABINET (July 15, 1988)
  • K860940 — MICROMEDICS STERILE, DISPOSABLE ENT EXAM KIT (May 2, 1986)
  • K855021 — LARYNGEAL MIRROR PRE-WARMER (March 20, 1986)

FDA data resources