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510(k) K832393

ENCODYNE 4 & VACUFIX 4 by Elmed, Inc.

K832393 is an FDA 510(k) premarket notification submitted by Elmed, Inc. for the device "ENCODYNE 4 & VACUFIX 4". The FDA issued a decision of Substantially Equivalent on November 14, 1983. Elmed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 1983
Date Received
July 19, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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)
  • K881431 — SIEMENS STEREODYNATOR 828 (April 16, 1990)

FDA data resources