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510(k) K862589

ULTRATHERM 808 I by Elmed, Inc. — Product Code IMJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 1986
Date Received
July 7, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5290
Review Panel
PM
Submission Type

Other clearances by Elmed, Inc.

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  • K952110 — ELMED THERMO-FLUX (August 14, 1995)
  • K926517 — ELMED LBC 50-P (November 15, 1994)
  • K932938 — ELMED ESU 300 M/M AND DIGITAL (May 2, 1994)
  • K921770 — ELECTROSURGICAL UNITS ESU 100L, 100 L M/M & E M/M (May 17, 1993)
  • K915731 — ELECTROSURGICAL UNITS ESU 30, 70, 70 B, 70 DIGITAL (November 5, 1992)
  • K905417 — ELMED PNEUMOMAT DIGITAL (January 31, 1991)
  • K881431 — SIEMENS STEREODYNATOR 828 (April 16, 1990)

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