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510(k) K951194

FI-10M by Pentax Precision Instrument Corp. — Product Code CAL

K951194 is an FDA 510(k) premarket notification submitted by Pentax Precision Instrument Corp. for the device "FI-10M". The FDA issued a decision of Substantially Equivalent on April 6, 1995. The device falls under product code CAL (Laryngoscope, Non-Rigid), a Class I device regulated under 21 CFR 868.5530. Pentax Precision Instrument Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 1995
Date Received
March 16, 1995
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 Pentax Precision Instrument Corp.

  • K041395 — EG-3630UR (June 9, 2004)
  • K041397 — EG-3830UT (June 9, 2004)
  • K041396 — FG-36UX FIBER ULTRASOUND GASTROSCOPE (June 9, 2004)
  • K031789 — EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE (August 8, 2003)
  • K023401 — EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE (February 11, 2003)
  • K023376 — EB-1830T3, VIDEO BRONCHOSCOPE (October 16, 2002)
  • K021276 — FG-36UX FIBER ULTRASOUND GASTROSCOPE (September 12, 2002)
  • K021278 — EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE (September 6, 2002)
  • K013640 — EG-3630UR, ULTRASUND VIDEO GASTROSCOPE (February 4, 2002)
  • K010740 — FG-36UX, FIBER ULTRASOUND GASTROSCOPE (April 17, 2001)

Other clearances for product code CAL

  • 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)
  • K802331 — AO FLEXIBLE LARYNGOSCOPE, #LS-7 (October 10, 1980)
  • K801364 — AO STYLET LARYNGOSCOPE MODEL SLS (June 17, 1980)
  • K791634 — AO STYLET LARYNGOSCOPE, MODEL SLS-1 (September 17, 1979)

FDA data resources