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510(k) K950785

HORTMANN AIRMATIC AIR CALORIC STIMULATOR by Jedmed Instrument Co. — Product Code KHH

K950785 is an FDA 510(k) premarket notification submitted by Jedmed Instrument Co. for the device "HORTMANN AIRMATIC AIR CALORIC STIMULATOR". The FDA issued a decision of Substantially Equivalent on June 28, 1995. The device falls under product code KHH (Stimulator, Caloric-Air), a Class I device regulated under 21 CFR 874.1800. Jedmed Instrument Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1995
Date Received
February 21, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Caloric-Air
Device Class
Class I
Regulation Number
874.1800
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)
  • K953457 — JEDMED SPECTRUM ENT CABINET (August 11, 1995)
  • K950925 — JEDMED LARYNGEAL SCOPE (August 11, 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 KHH

  • K946108 — EAR-A-GATOR (June 13, 1995)
  • K941325 — WATER IRRIGATOR, W1 200 (August 9, 1994)
  • K931608 — NCA-200 (June 22, 1993)
  • K925237 — AUTOMATIC CALORIC IRRIGATION SYSTEM (May 5, 1993)
  • K881630 — AUTOMATIC CALORIC IRRIGATION SYSTEM (June 21, 1988)
  • K822179 — FRENZEL EYEGLASSES & RELATED ITEMS (September 21, 1982)

FDA data resources