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510(k) K801364

AO STYLET LARYNGOSCOPE MODEL SLS by American Optical Corp. — Product Code CAL

K801364 is an FDA 510(k) premarket notification submitted by American Optical Corp. for the device "AO STYLET LARYNGOSCOPE MODEL SLS". The FDA issued a decision of Substantially Equivalent on June 17, 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
June 17, 1980
Date Received
June 10, 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)
  • K931354 — P4000 PHACOEMULSIFIER (February 22, 1994)
  • K931358 — AORP4000 REUSABLE PAK (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

  • K951195 — FI-10P (April 6, 1995)
  • K951194 — FI-10M (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)
  • K802331 — AO FLEXIBLE LARYNGOSCOPE, #LS-7 (October 10, 1980)
  • K791634 — AO STYLET LARYNGOSCOPE, MODEL SLS-1 (September 17, 1979)

FDA data resources