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510(k) K781032

AQUA-GEL by Murray, Salk, Inc. — Product Code EXQ

K781032 is an FDA 510(k) premarket notification submitted by Murray, Salk, Inc. for the device "AQUA-GEL". The FDA issued a decision of Substantially Equivalent on December 15, 1978. The device falls under product code EXQ (Cystometer, Electrical Recording), a Class II device regulated under 21 CFR 876.1620.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1978
Date Received
June 19, 1978
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

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  • K931282 — VOLUME TRANSDUCER (September 17, 1993)
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  • K920574 — CAMSYS 6300 (February 17, 1993)
  • K880391 — DACOMED CYSTOMETER (April 27, 1988)
  • K812177 — LIFE-TECH #1857 PRESSURE/POLOT MODULE (September 9, 1981)

FDA data resources