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510(k) K830984

OXYGEN CATHETERS by Medovations, Inc. — Product Code BZB

K830984 is an FDA 510(k) premarket notification submitted by Medovations, Inc. for the device "OXYGEN CATHETERS". The FDA issued a decision of Substantially Equivalent on May 18, 1983. The device falls under product code BZB (Catheter, Nasal, Oxygen), a Class I device regulated under 21 CFR 868.5350. Medovations, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 1983
Date Received
March 29, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Nasal, Oxygen
Device Class
Class I
Regulation Number
868.5350
Review Panel
AN
Submission Type

Other clearances by Medovations, Inc.

  • K142068 — BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON;PENTAX COMPATIBLE;DISPOSABLE RRIGATING (March 10, 2015)
  • K002363 — MEDOVATIONS ESOPHAGEAL DILATOR (November 1, 2000)
  • K972119 — MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX) (February 2, 1998)
  • K924646 — OVER THE GUIDEWIRE DILATATION SYSTEM (December 5, 1994)
  • K913678 — TROCAR CATHETER (December 16, 1991)
  • K905478 — YANKAUER SUCTION DEVICE (December 19, 1990)
  • K874309 — URETHAL CATHETER (December 7, 1987)
  • K864963 — STOMACH EVACULATOR - EWALD STYLE (October 14, 1987)
  • K864962 — OBERTO MOUTH PROP (February 19, 1987)
  • K864964 — 5 - IN - 1 CONNECTOR (January 20, 1987)

Other clearances for product code BZB

  • K896731 — OXYGEN CATHETERS (March 30, 1990)
  • K843466 — PHARMA-PLAST OXYGEN CATHETER (November 19, 1984)
  • K833351 — DEMAND OXYGEN CONTROLLER (March 19, 1984)
  • K820370 — NASAL OXYGEN CATHETER (April 16, 1982)
  • K800506 — OXYGEN CATHETER (March 25, 1980)
  • K791273 — CONPHAR OXYGEN CATHETER-STERILE (July 24, 1979)
  • K790057 — CATHETER, OXYGEN (February 5, 1979)

FDA data resources