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510(k) K842410

AMER. EDWARDS LAB FLEXISCOPE by American Edwards Laboratories — Product Code HRK

K842410 is an FDA 510(k) premarket notification submitted by American Edwards Laboratories for the device "AMER. EDWARDS LAB FLEXISCOPE". The FDA issued a decision of Substantially Equivalent on November 5, 1984. The device falls under product code HRK (Table, Instrument, Manual, Ophthalmic), a Class I device regulated under 21 CFR 886.4855. American Edwards Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1984
Date Received
June 19, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Instrument, Manual, Ophthalmic
Device Class
Class I
Regulation Number
886.4855
Review Panel
OP
Submission Type

Other clearances by American Edwards Laboratories

  • K873485 — EDSLAB (R) OCCLUSION BALLOON CATHETER (December 3, 1987)
  • K872596 — TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30 (September 30, 1987)
  • K872529 — THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2 (September 15, 1987)
  • K870444 — HOMEPRO II VOLUMETRIC INFUSION PUMP (April 17, 1987)
  • K864997 — MEDTRAC VP VOLUMETRIC INFUSION PUMP (February 27, 1987)
  • K864330 — SHEAR FORCE GAUGE (January 6, 1987)
  • K862724 — VEIN VALVE CUTTER (January 2, 1987)
  • K863596 — CHIN-FOGARTY INFLATION DEVICE (November 20, 1986)
  • K864155 — MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS (November 20, 1986)
  • K863986 — XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES (October 31, 1986)

Other clearances for product code HRK

  • K760697 — EVANS ARM AND HAND REST (November 2, 1976)

FDA data resources