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510(k) K883154

SELDIX 325 TWO PULSE GENERATOR/CONTROL by Bay X-Ray, Inc. — Product Code IZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 1988
Date Received
July 26, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, High-Voltage, X-Ray, Diagnostic
Device Class
Class I
Regulation Number
892.1700
Review Panel
RA
Submission Type

Other clearances by Bay X-Ray, Inc.

  • K883161 — HIMOBILIX 2N (October 21, 1988)
  • K883160 — CATAPULT BUCKY (KATAPULT BLENDA) (September 8, 1988)
  • K883162 — TELESTATIX X-RAY TABLE (September 6, 1988)
  • K883155 — RASTIX X-RAY TABLE (September 6, 1988)
  • K883153 — UNDISTAT WITH EXPLORATOR 35 (UCS 35E) (September 6, 1988)

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  • K953831 — N 800 HF (September 8, 1995)
  • K952822 — SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G (July 12, 1995)
  • K952265 — MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X- (July 6, 1995)
  • K950883 — POLYDOROS SX 65 AND 80 (April 3, 1995)
  • K950694 — COMPACT-X (March 31, 1995)
  • K950291 — DIGITAL 625HF (March 23, 1995)
  • K950041 — SII 360 APR (March 21, 1995)
  • K945453 — UD 150L-R II (March 21, 1995)