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510(k) K822917

MODEL 5400 OPTOKINETIC STIMULATOR by Life-Tech Intl., Inc. — Product Code HOW

K822917 is an FDA 510(k) premarket notification submitted by Life-Tech Intl., Inc. for the device "MODEL 5400 OPTOKINETIC STIMULATOR". The FDA issued a decision of Substantially Equivalent on November 1, 1982. The device falls under product code HOW (Drum, Opticokinetic), a Class I device regulated under 21 CFR 886.1200. Life-Tech Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1982
Date Received
October 1, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drum, Opticokinetic
Device Class
Class I
Regulation Number
886.1200
Review Panel
OP
Submission Type

Other clearances by Life-Tech Intl., Inc.

  • K001129 — PROLONG, MODELS PL50, PL100, PL150 (July 6, 2000)
  • K954505 — EZ STIM (December 10, 1996)
  • K955031 — MAXISTIM (December 10, 1996)
  • K954315 — PVC ABDOMINAL/RECTAL PRESSURE CATHETER (November 30, 1995)
  • K954341 — URODYNAMICS TUBING AND INFUSION SETS (October 17, 1995)
  • K953451 — UROPUMP TUBE & DAMPING CHAMGER (October 5, 1995)
  • K953353 — UROVISION JANUS (September 8, 1995)
  • K946108 — EAR-A-GATOR (June 13, 1995)
  • K913601 — MICROPHOR (July 15, 1994)
  • K940203 — TRIPLE LUMEN URODYNAMIC CATHETER WITH RADIOPAQUE MARKERS (March 30, 1994)

FDA data resources