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510(k) K802331

AO FLEXIBLE LARYNGOSCOPE, #LS-7 by American Optical Corp. — Product Code CAL

K802331 is an FDA 510(k) premarket notification submitted by American Optical Corp. for the device "AO FLEXIBLE LARYNGOSCOPE, #LS-7". The FDA issued a decision of Substantially Equivalent on October 10, 1980. The device falls under product code CAL (Laryngoscope, Non-Rigid), a Class I device regulated under 21 CFR 868.5530. American Optical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1980
Date Received
September 23, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laryngoscope, Non-Rigid
Device Class
Class I
Regulation Number
868.5530
Review Panel
AN
Submission Type

Other clearances by American Optical Corp.

  • K950881 — PHACO TIP (September 6, 1995)
  • K950880 — AOI UNIVERSAL ULTRASONIC HANDPIECE (May 26, 1995)
  • K931358 — AORP4000 REUSABLE PAK (February 22, 1994)
  • K931354 — P4000 PHACOEMULSIFIER (February 22, 1994)
  • K931357 — AOD4000 DISPOSABLE PAK (January 25, 1994)
  • K820790 — FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3 (April 1, 1982)
  • K813430 — TISSUE PROCESSING CASSETTES & ACCESS (December 29, 1981)
  • K812965 — MODEL SC-6, FLEXIBLE SIAMOIDOSCOPE (November 2, 1981)
  • K812051 — PHOTOLITE AOLITE TINTOMATIC LENS (September 8, 1981)
  • K812063 — SR-1V DATA PRINTER (August 18, 1981)

Other clearances for product code CAL

  • K951194 — FI-10M (April 6, 1995)
  • K951195 — FI-10P (April 6, 1995)
  • K872895 — HAEMONETICS CELL SAVER MINI SAVER AUTO. BLOOD SYS. (January 11, 1988)
  • K852994 — REICHERT FLEXIBLE LARYNGOSCOPE, MODEL LS-11 (July 29, 1985)
  • K850978 — OLYMPUS LF-1 INTUBATION SCOPE (May 23, 1985)
  • K801364 — AO STYLET LARYNGOSCOPE MODEL SLS (June 17, 1980)
  • K791634 — AO STYLET LARYNGOSCOPE, MODEL SLS-1 (September 17, 1979)

FDA data resources