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510(k) K771368

PORTABLE INFANT VENTILATOR by Cavitron Corp. — Product Code FOC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1977
Date Received
July 25, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bag, Urine Collection, Newborn
Device Class
Class II
Regulation Number
876.5250
Review Panel
GU
Submission Type

Other clearances by Cavitron Corp.

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  • K810207 — MINOR SURGERY LIGHT (February 13, 1981)
  • K802928 — SPIROMETRIC COMPUTER #SC-10 (December 17, 1980)
  • K801623 — CAVITRON ULTRASONIC SURG. ASPIR. CUSA (November 18, 1980)
  • K801877 — SLIT LAMP ATTACHMENT (September 16, 1980)
  • K800869 — MODEL PM-20(N)(R)CO2 PATIENT MONITOR/ALA (May 28, 1980)
  • K800722 — AUTO-FIELD D AUTOMATED VISUAL DETECTOR (April 29, 1980)
  • K791585 — MODEL G-61 ULTRASONIC DENTAL UNIT (September 19, 1979)
  • K791277 — MODEL 6500 EXTRACTION IRRIGATION SYS (August 22, 1979)
  • K782054 — LASER, CO2 SURGICAL (January 17, 1979)

Other clearances for product code FOC

  • K950176 — PREMIE U-BAG URINE SPECIMEN COLLECTOR (February 7, 1995)
  • K943752 — RIMECO MIDSTREAM URINE COLLECTOR (November 1, 1994)
  • K911329 — BARD(R) SURECATCH PEDIATRIC URINE COLLECT DEVICE (May 28, 1991)