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510(k) K834089

COMFIT by Ackrad Laboratories — Product Code JAY

K834089 is an FDA 510(k) premarket notification submitted by Ackrad Laboratories for the device "COMFIT". The FDA issued a decision of Substantially Equivalent on December 29, 1983. The device falls under product code JAY (Support, Breathing Tube), a Class I device regulated under 21 CFR 868.5280. Ackrad Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1983
Date Received
November 28, 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 by Ackrad Laboratories

  • K021272 — SIB CATHETER, MODEL 61-7005 (May 21, 2002)
  • K020954 — H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TR (April 24, 2002)
  • K020951 — H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007 (April 16, 2002)
  • K970492 — INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER (April 9, 1997)
  • K961752 — H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) (August 8, 1996)
  • K940176 — ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION (April 23, 1996)
  • K952542 — ACKRAD ESOPHAGEAL BALLOON CATHETER SET (April 23, 1996)
  • K953034 — H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) (August 29, 1995)
  • K915813 — ACKRAD ERCP CONTRAST DELIVERY SET (March 11, 1992)
  • K904499 — NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM) (July 1, 1991)

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)
  • K833361 — TUBE-TITLE (November 3, 1983)
  • K833374 — BITE-BLOCK (November 3, 1983)
  • K833332 — SCHULTZ ENDHOLD (October 31, 1983)

FDA data resources