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510(k) K881431

SIEMENS STEREODYNATOR 828 by Elmed, Inc. — Product Code IPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1990
Date Received
April 5, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type

Other clearances by Elmed, Inc.

  • K010465 — DENSTAT (May 14, 2001)
  • K974793 — ELMED ESU 120 M/M DIGITAL (March 19, 1998)
  • K953271 — ELMED RF-ALERT (January 18, 1996)
  • 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)
  • K875238 — SIEMENS NEUROTON 826 AND 827 (March 10, 1988)

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