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510(k) K920983

SONOPULS 590 by Henley Intl. — Product Code IMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1993
Date Received
March 2, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5300
Review Panel
PM
Submission Type

Other clearances by Henley Intl.

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  • K926287 — EXERCISE BICYCLE (March 22, 1994)
  • K926314 — HYDRA FITNESS MODEL 311 TOTAL POWER (March 18, 1994)
  • K926313 — COMPUTERIZED TESTING AND EXERCISE SYSTEMS (February 4, 1994)
  • K915864 — MONOTRODE CUTANEOUS ELECTRODE (July 21, 1993)
  • K922036 — SONOPULS 591 (June 29, 1993)
  • K926316 — TRUE-TRAC, STRATUS (March 24, 1993)
  • K922020 — ENDOMED 582 (September 22, 1992)

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