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510(k) K880050

EDEC 60R by Electromed Intl., Ltd. — Product Code IZO

K880050 is an FDA 510(k) premarket notification submitted by Electromed Intl., Ltd. for the device "EDEC 60R". The FDA issued a decision of Substantially Equivalent on February 29, 1988. The device falls under product code IZO (Generator, High-Voltage, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1700. Electromed Intl., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 29, 1988
Date Received
January 6, 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 Electromed Intl., Ltd.

  • K003688 — VIEW READING STATION (January 22, 2001)
  • K000474 — VIEW NT (April 19, 2000)
  • K990759 — VIEW COM (April 15, 1999)
  • K974255 — CD-R STATION AND VRS-2000 (January 27, 1998)
  • K971176 — VIEW ARCHIVING STATION (September 3, 1997)
  • K950694 — COMPACT-X (March 31, 1995)
  • K875341 — EDEC 60 R/F (February 1, 1988)
  • K875342 — EDEC 90C (January 29, 1988)
  • K871145 — EDEC 50C CONSTANT POTENTIAL X-RAY GENERATOR (March 31, 1987)
  • K870851 — EDEC 80 CONSTANT POTENTIAL X-RAY GENERATOR (March 20, 1987)

Other clearances for product code IZO

  • K954666 — MPH50, MPH65, AND MPH80 (November 24, 1995)
  • K953582 — HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR (September 26, 1995)
  • 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)
  • K950040 — SII 525 APR (March 21, 1995)

FDA data resources