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510(k) K850924

JEE FRAME (VENTILATOR CIRCUIT SUPPORT) by Vulcan Laboratories, Inc. — Product Code JAY

K850924 is an FDA 510(k) premarket notification submitted by Vulcan Laboratories, Inc. for the device "JEE FRAME (VENTILATOR CIRCUIT SUPPORT)". The FDA issued a decision of Substantially Equivalent on July 19, 1985. The device falls under product code JAY (Support, Breathing Tube), a Class I device regulated under 21 CFR 868.5280. Vulcan Laboratories, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1985
Date Received
March 5, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Support, Breathing Tube
Device Class
Class I
Regulation Number
868.5280
Review Panel
AN
Submission Type

Other clearances by Vulcan Laboratories, Inc.

  • K851451 — STAT GAS MODULE (August 2, 1985)

Other clearances for product code JAY

  • K944988 — CUSTOM MEDICAL SUSPENSION STRAP (January 27, 1995)
  • K873491 — BLOCK, BITE, INTUBATION (October 20, 1987)
  • K860583 — DALE HEAD BAND ANESTHESIA CIRCUIT TUBE HOLDER 1315 (February 21, 1986)
  • K850309 — COMFIT PLUS ENDOTRACHEAL TUBE HOLDER & BITE BLOCK (February 14, 1985)
  • K840844 — ENDO-SECURE (March 16, 1984)
  • K834265 — TRACH MATE (January 4, 1984)
  • K834089 — COMFIT (December 29, 1983)
  • K833374 — BITE-BLOCK (November 3, 1983)
  • K833361 — TUBE-TITLE (November 3, 1983)
  • K833332 — SCHULTZ ENDHOLD (October 31, 1983)

FDA data resources