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510(k) K930338

ORTHOCEPH OC100 by Instrumentarium Corp. — Product Code EHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 1993
Date Received
January 25, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, X-Ray, Extraoral With Timer
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type

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  • K934478 — ALPHA STEREO (January 31, 1995)
  • K923433 — AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE (July 22, 1993)

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