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510(k) K931282

VOLUME TRANSDUCER by Life-Tech Intl., Inc. — Product Code EXQ

K931282 is an FDA 510(k) premarket notification submitted by Life-Tech Intl., Inc. for the device "VOLUME TRANSDUCER". The FDA issued a decision of Substantially Equivalent on September 17, 1993. The device falls under product code EXQ (Cystometer, Electrical Recording), a Class II device regulated under 21 CFR 876.1620. Life-Tech Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1993
Date Received
March 12, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cystometer, Electrical Recording
Device Class
Class II
Regulation Number
876.1620
Review Panel
GU
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)

Other clearances for product code EXQ

  • K253537 — Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics Sy (April 16, 2026)
  • K243052 — Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics Sy (March 24, 2025)
  • K931574 — ADVANCE MODEL UDS-ADV (August 5, 1993)
  • K920574 — CAMSYS 6300 (February 17, 1993)
  • K880391 — DACOMED CYSTOMETER (April 27, 1988)
  • K812177 — LIFE-TECH #1857 PRESSURE/POLOT MODULE (September 9, 1981)
  • K781032 — AQUA-GEL (December 15, 1978)

FDA data resources