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510(k) K780964

TRANSPORT INCUBATOR by Cavitron Corp. — Product Code FPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1978
Date Received
June 12, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Incubator, Neonatal Transport
Device Class
Class II
Regulation Number
880.5410
Review Panel
HO
Submission Type

Other clearances by Cavitron Corp.

  • K811582 — THE PLACER (July 28, 1981)
  • 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 FPL

  • K220742 — NxtGen Infant Transport Incubator (July 15, 2022)
  • K161918 — SREE MRI Transport Incubator (March 3, 2017)
  • K141565 — GLOBE-TROTTER GT5400 (September 10, 2014)
  • K123937 — ATOM TRANSCAPSULE V-707 (May 23, 2013)
  • K103523 — 185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NE (May 11, 2011)
  • K103525 — A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NE (May 11, 2011)
  • K103527 — AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WIT (April 15, 2011)
  • K103524 — VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WIT (April 15, 2011)
  • K081399 — AVIATOR TRANSPORT INCUBATOR (June 6, 2008)
  • K061071 — V-808 ATOM TRANSCAPSULE (August 29, 2006)