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510(k) K823246

AUSTIN INHALATOR by Ems Industries, Inc. — Product Code BYX

K823246 is an FDA 510(k) premarket notification submitted by Ems Industries, Inc. for the device "AUSTIN INHALATOR". The FDA issued a decision of Substantially Equivalent on December 16, 1982. The device falls under product code BYX (Tubing, Pressure And Accessories), a Class I device regulated under 21 CFR 868.5860. Ems Industries, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1982
Date Received
November 1, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubing, Pressure And Accessories
Device Class
Class I
Regulation Number
868.5860
Review Panel
AN
Submission Type

Other clearances by Ems Industries, Inc.

  • K823247 — U-WAY QUICKOLLAR (November 16, 1982)

Other clearances for product code BYX

  • K011134 — OXYGEN SUPPLY TUBING, MODEL 1115 (June 13, 2001)
  • K955656 — NORTH STATE PLASTICS AEROSOL TEE (March 6, 1996)
  • K943110 — GAS SAMPLING INTERFACES (August 19, 1994)
  • K935835 — BUSSE PLASTIC TUBING CONNECTORS AND ACCESSORIES (January 12, 1994)
  • K931033 — MF CHEMETRON STYLE MEDICAL GAS WALL OUTLETS (June 1, 1993)
  • K931043 — MF OHMEDA STYLE MEDICAL GAS WALL OUTLETS (June 1, 1993)
  • K913422 — OXYGEN TUBING, 81503 (January 30, 1992)
  • K914980 — HEX, QUAD, OR RAIL BLOCK MANIFOLD ACCESSORIES (January 21, 1992)
  • K912763 — OHMEDA STYLE CHECK UNITS (FEMALE COUPLERS) (October 15, 1991)
  • K905091 — VARIOUS MALE QUICK CONNECTS. (March 4, 1991)

FDA data resources