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510(k) K802251

SP 120 SOPHISTICATE by Vickers America Medical Corp. — Product Code JQP

K802251 is an FDA 510(k) premarket notification submitted by Vickers America Medical Corp. for the device "SP 120 SOPHISTICATE". The FDA issued a decision of Substantially Equivalent on October 23, 1980. The device falls under product code JQP (Calculator/Data Processing Module, For Clinical Use), a Class I device regulated under 21 CFR 862.2100. Vickers America Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1980
Date Received
September 16, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator/Data Processing Module, For Clinical Use
Device Class
Class I
Regulation Number
862.2100
Review Panel
CH
Submission Type

Other clearances by Vickers America Medical Corp.

  • K840823 — TREONIC C30 (March 23, 1984)
  • K831838 — LABORATORY DATA MGMT SYSTEM SDMS (January 24, 1984)
  • K830748 — RESUSCITAIRE (June 22, 1983)
  • K830936 — TREONIC IP5 (April 12, 1983)
  • K813239 — OXYGENAIRE NURING INCUBATOR (January 28, 1982)
  • K813238 — NEOCARE BABY-CONTROLLED INCUBATOR (January 22, 1982)
  • K811865 — VMA PEDIATRIC APNEA MATTRESS (July 31, 1981)
  • K810792 — NEOCARE TEMPERATURE MONITOR (April 29, 1981)
  • K810067 — 140 NEOCARE AIR CONTROLLED INCUBATOR (March 11, 1981)
  • K810571 — NEOCARE OXYGEN MONITOR (March 11, 1981)

Other clearances for product code JQP

  • K113007 — BIONIME DIABETES MANAGEMENT SYSTEM VI.0 (February 27, 2012)
  • K983468 — FASTTAKE ADAPTER, MODEL # P/N 020-072-01 (December 17, 1998)
  • K964460 — THE ROBOLITE (January 24, 1997)
  • K953652 — PRENVAL I (September 15, 1995)
  • K934111 — MR7000 WITH TIME MANAGER SOFTWARE (TMS) (November 2, 1994)
  • K923316 — EXPRESSO CARTRIDGE (February 23, 1993)
  • K893838 — MODIFIED MODEL 570 CLINICAL CHEMISTRY ANALYZER (August 31, 1989)
  • K892060 — CYBERLAB HIGH VOLUME DRUG TESTING SYSTEM (August 10, 1989)
  • K885292 — COBAS MFC (March 22, 1989)
  • K881194 — RIA-QUICK (June 1, 1988)

FDA data resources