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510(k) K834265

TRACH MATE by Tempe Biomedical, Inc. — Product Code JAY

K834265 is an FDA 510(k) premarket notification submitted by Tempe Biomedical, Inc. for the device "TRACH MATE". The FDA issued a decision of Substantially Equivalent on January 4, 1984. The device falls under product code JAY (Support, Breathing Tube), a Class I device regulated under 21 CFR 868.5280.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 1984
Date Received
December 8, 1983
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 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)
  • K850924 — JEE FRAME (VENTILATOR CIRCUIT SUPPORT) (July 19, 1985)
  • K850309 — COMFIT PLUS ENDOTRACHEAL TUBE HOLDER & BITE BLOCK (February 14, 1985)
  • K840844 — ENDO-SECURE (March 16, 1984)
  • K834089 — COMFIT (December 29, 1983)
  • K833361 — TUBE-TITLE (November 3, 1983)
  • K833374 — BITE-BLOCK (November 3, 1983)
  • K833332 — SCHULTZ ENDHOLD (October 31, 1983)

FDA data resources