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510(k) K830229

ROENTGENOGRAPHY SET by Mallinckrodt Critical Care — Product Code DGD

K830229 is an FDA 510(k) premarket notification submitted by Mallinckrodt Critical Care for the device "ROENTGENOGRAPHY SET". The FDA issued a decision of Substantially Equivalent on March 9, 1983. The device falls under product code DGD (Igg, Ferritin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Mallinckrodt Critical Care has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1983
Date Received
January 24, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igg, Ferritin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

Other clearances by Mallinckrodt Critical Care

  • K880343 — BURNEY GALLBLADDER CATHETER KIT (May 1, 1989)
  • K874605 — HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR (February 2, 1988)
  • K874514 — HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE (January 29, 1988)
  • K874568 — HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR (January 6, 1988)
  • K873461 — LASER-FLEX(TM) TRACHEAL TUBE (CUFFED) (November 6, 1987)
  • K874404 — HI-LO TEMP(R) SKIN TEMPERATURE SENSOR (November 6, 1987)
  • K873833 — THERMOCOUPLE ADAPTER (November 3, 1987)
  • K873004 — GUIDING CATHETER (September 15, 1987)
  • K871204 — CUFFED TRACHEAL TUBE (MULTIPLE) (April 21, 1987)
  • K862666 — UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE) (August 1, 1986)

Other clearances for product code DGD

  • K946266 — FERRITIN CONTROL - LEVEL 1, 2, 3 (February 10, 1995)
  • K881345 — IMX FERRITIN (May 11, 1988)

FDA data resources