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510(k) K833420

KINETIX MOUTHPIECE by Kinetix — Product Code BYP

K833420 is an FDA 510(k) premarket notification submitted by Kinetix for the device "KINETIX MOUTHPIECE". The FDA issued a decision of Substantially Equivalent on January 10, 1984. The device falls under product code BYP (Mouthpiece, Breathing), a Class I device regulated under 21 CFR 868.5620. Kinetix has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1984
Date Received
October 3, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mouthpiece, Breathing
Device Class
Class I
Regulation Number
868.5620
Review Panel
AN
Submission Type

Other clearances by Kinetix

  • K832401 — RESPIROMETER (April 30, 1984)
  • K840459 — IMPROVED MOUTHPIECE (February 17, 1984)
  • K833012 — INSPIROMETER (November 8, 1983)

Other clearances for product code BYP

  • K955657 — NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE (March 12, 1996)
  • K944512 — TRUZONE PFM DISPOSABLE MOUTHPIECE (November 2, 1994)
  • K893791 — BREATHING MOUTHPIECE (June 23, 1989)
  • K872037 — AEROCHAMBER (July 24, 1987)
  • K865093 — SAFE-T-SHIELD MOUTHPIECE (January 15, 1987)
  • K863049 — INHALATION AID (October 15, 1986)
  • K862788 — MP-4400 MOUTHPIECE-FLANGE SEAL (August 1, 1986)
  • K853266 — PLASTIC MOUTH BARRIER HSV-I (October 29, 1985)
  • K853574 — MEDIPART DISPOS. MOUTHPIECE W/22MM O.D. MP-4411 (October 29, 1985)
  • K853575 — MEDIPART MOUTHPIECE MP-1010 (October 29, 1985)

FDA data resources