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510(k) K961207

EP-X BIPLANE by Fischer Imaging Corp. — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1996
Date Received
March 27, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

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  • K945619 — ATHENA HFX (March 23, 1995)
  • K944150 — MICRO X-65 HF (September 16, 1994)
  • K944148 — MICRO X-30HF (September 16, 1994)

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