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510(k) K802675

ENDOTRACHEAL TUBE HOLDER by Respiratory Support Products, Inc. — Product Code JAY

K802675 is an FDA 510(k) premarket notification submitted by Respiratory Support Products, Inc. for the device "ENDOTRACHEAL TUBE HOLDER". The FDA issued a decision of Substantially Equivalent on November 19, 1980. The device falls under product code JAY (Support, Breathing Tube), a Class I device regulated under 21 CFR 868.5280. Respiratory Support Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1980
Date Received
October 29, 1980
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 Respiratory Support Products, Inc.

  • K983862 — CLOUD 1 HUMIDIFICATION SYSTEM (May 24, 1999)
  • K921190 — ADAP-TEMP TEMPERATURE SENSOR ADAPTER (March 9, 1993)
  • K920469 — MYOCARDINAL TEMPERATURE SENSOR WITH TYPE 400 SERIE (September 11, 1992)
  • K921510 — GAS SAMPLING KIT MODIFICATION (June 11, 1992)
  • K913082 — BI-TEMP TEMPERATURE MONITOR,MODEL TM-300D (December 11, 1991)
  • K913083 — BI-TEMP TEMPERATURE MONITOR TM-201D (October 17, 1991)
  • K912280 — BI-TEMP TEMPERATURE MONITOR, MODEL TM-400D (October 17, 1991)
  • K903816 — URINE METER FOLEY TRAY WITH TEMPERATURE SENSOR (October 31, 1990)
  • K874694 — ADAP-TEMP, MODEL: AT-100 (March 1, 1988)
  • K873472 — MEMBRANE HUMIDIFIER (January 19, 1988)

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)
  • K834265 — TRACH MATE (January 4, 1984)
  • K834089 — COMFIT (December 29, 1983)
  • K833374 — BITE-BLOCK (November 3, 1983)
  • K833361 — TUBE-TITLE (November 3, 1983)

FDA data resources