Home / 510(k) Clearances / K827450

510(k) K827450

SIMPLAMATIC III by Spectrum X-Ray Corp.

K827450 is an FDA 510(k) premarket notification submitted by Spectrum X-Ray Corp. for the device "SIMPLAMATIC III". The FDA issued a decision of Substantially Equivalent on May 19, 1982. Spectrum X-Ray Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 1982
Date Received
April 27, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Spectrum X-Ray Corp.

  • K933134 — SPECTRUM DG-P7000 PEDIATRIC CRADLE (October 7, 1993)
  • K931563 — SPECTRUM MARK I SPECIAL PROCEDURES TABLE (August 23, 1993)
  • K870707 — PENTAMAX 1 MODEL B TABLE SYSTEM (May 14, 1987)
  • K840463 — DIGITAL CRADLE (February 21, 1984)
  • K834494 — SPECTRUM X-RAY CORP (February 21, 1984)
  • K813561 — SPECTRUM PEDIATRIC CARDLE TABLE (January 29, 1982)
  • K791812 — SPECTRUM EMERGENCY & TRAUMA TABLE SYSTEM (November 5, 1979)
  • K791811 — SPECTRUM AUTOMATIC CHEST UNIT MODEL C (October 26, 1979)

FDA data resources