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510(k) K820354

ATMOS MIRROR WARMER by Jedmed Instrument Co. — Product Code KAI

K820354 is an FDA 510(k) premarket notification submitted by Jedmed Instrument Co. for the device "ATMOS MIRROR WARMER". The FDA issued a decision of Substantially Equivalent on March 1, 1982. The device falls under product code KAI (Mirror, Ent), a Class I device regulated under 21 CFR 874.4420. Jedmed Instrument Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1982
Date Received
February 8, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mirror, Ent
Device Class
Class I
Regulation Number
874.4420
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)
  • 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 KAI

  • K833601 — ANTRUM & ATTIC MIRROR (January 3, 1984)
  • K823915 — MIRROR TIP (January 21, 1983)
  • K822374 — BUCKINGHAM ATTIC & ANTRUM MIRROR (September 9, 1982)
  • K822261 — LARYNGEAL MIRRORS (August 30, 1982)
  • K822191 — HEAD MIRROR WITH HEADBAND (August 20, 1982)
  • K781750 — MIRROR WARMER (January 17, 1979)
  • K770053 — MIRROR, LARYNGEAL (January 18, 1977)
  • K770054 — MIRROR, NASO-PHARYNX (January 18, 1977)

FDA data resources