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510(k) K813561

SPECTRUM PEDIATRIC CARDLE TABLE by Spectrum X-Ray Corp. — Product Code KXH

K813561 is an FDA 510(k) premarket notification submitted by Spectrum X-Ray Corp. for the device "SPECTRUM PEDIATRIC CARDLE TABLE". The FDA issued a decision of Substantially Equivalent on January 29, 1982. The device falls under product code KXH (Cradle, Patient, Radiologic), a Class I device regulated under 21 CFR 892.1830. Spectrum X-Ray Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1982
Date Received
December 22, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cradle, Patient, Radiologic
Device Class
Class I
Regulation Number
892.1830
Review Panel
RA
Submission Type

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)
  • K834494 — SPECTRUM X-RAY CORP (February 21, 1984)
  • K840463 — DIGITAL CRADLE (February 21, 1984)
  • K827450 — SIMPLAMATIC III (May 19, 1982)
  • K791812 — SPECTRUM EMERGENCY & TRAUMA TABLE SYSTEM (November 5, 1979)
  • K791811 — SPECTRUM AUTOMATIC CHEST UNIT MODEL C (October 26, 1979)

Other clearances for product code KXH

  • K122174 — PEDIATRIC POSITIONER PAD SET (November 16, 2012)
  • K953246 — OCTOROLL (September 29, 1995)
  • K930124 — VARIANT OF OCTOSTOP AND OCTOPAQUE (February 9, 1994)
  • K933134 — SPECTRUM DG-P7000 PEDIATRIC CRADLE (October 7, 1993)
  • K930357 — ACCESSORY TO UNIVERSAL OCTOPAQUE (July 13, 1993)
  • K884292 — STRETCHER TABLE (March 31, 1989)
  • K863890 — MAMM-AIRE (October 14, 1986)
  • K840463 — DIGITAL CRADLE (February 21, 1984)

FDA data resources