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510(k) K802251

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

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

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  • 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)
  • K810571 — NEOCARE OXYGEN MONITOR (March 11, 1981)
  • K810067 — 140 NEOCARE AIR CONTROLLED INCUBATOR (March 11, 1981)

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