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510(k) K921285

9105 RIGID TELESCOPIC ENDOSCOPE by Kay Elemetrics Corp. — Product Code EQL

K921285 is an FDA 510(k) premarket notification submitted by Kay Elemetrics Corp. for the device "9105 RIGID TELESCOPIC ENDOSCOPE". The FDA issued a decision of Substantially Equivalent on May 28, 1992. The device falls under product code EQL (Laryngostroboscope), a Class I device regulated under 21 CFR 874.4750. Kay Elemetrics Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1992
Date Received
March 17, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laryngostroboscope
Device Class
Class I
Regulation Number
874.4750
Review Panel
EN
Submission Type

Other clearances by Kay Elemetrics Corp.

  • K991738 — DIGITAL VIDEO RECORDING SYSTEM (August 13, 1999)
  • K990240 — ELECTROGLOTTOGRAPH (March 11, 1999)
  • K954798 — 7100 SWALLOWING WORKSTATION (June 4, 1996)
  • K921184 — RLS 9100 RHINO-LARYNGEAL STROBOSCOPE (May 28, 1992)

Other clearances for product code EQL

  • K984521 — RIWO DRIVE SYSTEM 2302 WITH GENERATOR, SMALL MOTOR HANDLES, 8563.111, 8563.351 (March 17, 1999)
  • K921184 — RLS 9100 RHINO-LARYNGEAL STROBOSCOPE (May 28, 1992)
  • K884933 — ENDOSTROBOSCOPE IV (February 15, 1989)
  • K842090 — RHINO-LARYNX STROBOSCOPE TYPE 4914 (July 18, 1984)
  • K822523 — LARYNGOSTROBOSCOPE (September 9, 1982)
  • K801866 — PENTAX LARYNGO-STROBOSCOPE MODEL LS-1A (September 16, 1980)
  • K770466 — STOCKINGS, RVS TM (March 28, 1977)

FDA data resources