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510(k) K811865

VMA PEDIATRIC APNEA MATTRESS by Vickers America Medical Corp. — Product Code BZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1981
Date Received
July 1, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Breathing Frequency
Device Class
Class II
Regulation Number
868.2375
Review Panel
AN
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)
  • K810792 — NEOCARE TEMPERATURE MONITOR (April 29, 1981)
  • K810571 — NEOCARE OXYGEN MONITOR (March 11, 1981)
  • K810067 — 140 NEOCARE AIR CONTROLLED INCUBATOR (March 11, 1981)
  • K802251 — SP 120 SOPHISTICATE (October 23, 1980)

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