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510(k) K883161

HIMOBILIX 2N by Bay X-Ray, Inc. — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 1988
Date Received
July 26, 1988
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

Other clearances by Bay X-Ray, Inc.

  • K883160 — CATAPULT BUCKY (KATAPULT BLENDA) (September 8, 1988)
  • K883162 — TELESTATIX X-RAY TABLE (September 6, 1988)
  • K883155 — RASTIX X-RAY TABLE (September 6, 1988)
  • K883154 — SELDIX 325 TWO PULSE GENERATOR/CONTROL (September 6, 1988)
  • K883153 — UNDISTAT WITH EXPLORATOR 35 (UCS 35E) (September 6, 1988)

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