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510(k) K920574

CAMSYS 6300 by F.M. Wiest USA, Inc. — Product Code EXQ

K920574 is an FDA 510(k) premarket notification submitted by F.M. Wiest USA, Inc. for the device "CAMSYS 6300". The FDA issued a decision of Substantially Equivalent on February 17, 1993. The device falls under product code EXQ (Cystometer, Electrical Recording), a Class II device regulated under 21 CFR 876.1620. F.M. Wiest USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 1993
Date Received
February 7, 1992
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 F.M. Wiest USA, Inc.

  • K921871 — HYSTEROMAT(TM) 3700 (December 15, 1994)
  • K920575 — MERKUR 4000 (July 23, 1992)
  • K915751 — URETEROMAT 4400 (April 24, 1992)
  • K911844 — HYSTEROFLATOR 1500 (November 21, 1991)
  • K912071 — SPACE(TM) 7500 (July 9, 1991)
  • K910883 — LAPAROFLATOR ELECTRONIC 3509 (March 29, 1991)
  • K875137 — LAPAROFLATOR 3000, STANDARD AND ELECTRONIC (March 2, 1988)
  • K871181 — ARTHROCOMBI 5003 (September 29, 1987)
  • K871180 — ARTHRO AUTOMAT 5002 (September 29, 1987)
  • K865066 — ARTHROFLATOR (April 20, 1987)

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)
  • K931282 — VOLUME TRANSDUCER (September 17, 1993)
  • K931574 — ADVANCE MODEL UDS-ADV (August 5, 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