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510(k) K881812

AERO-MIST NEBULIZER by Cadema Medical Products, Inc. — Product Code IYT

K881812 is an FDA 510(k) premarket notification submitted by Cadema Medical Products, Inc. for the device "AERO-MIST NEBULIZER". The FDA issued a decision of Substantially Equivalent on July 18, 1988. The device falls under product code IYT (System, Rebreathing, Radionuclide), a Class II device regulated under 21 CFR 892.1390. Cadema Medical Products, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1988
Date Received
April 28, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Rebreathing, Radionuclide
Device Class
Class II
Regulation Number
892.1390
Review Panel
RA
Submission Type

Other clearances by Cadema Medical Products, Inc.

  • K901476 — MODIFIED ENTRAPPING FILTER (May 1, 1990)
  • K896773 — DISPOSABLE FACE MASK (January 12, 1990)
  • K896116 — ENTRAPPING FILTER (November 17, 1989)
  • K873930 — AEROSOL DELIVERY SYSTEM (AERO-TECH II) (December 7, 1987)
  • K800023 — LUNG AEROSOL UNIT (January 1, 1985)

Other clearances for product code IYT

  • K253942 — Pulmonex II Xenon System (132-503) (July 7, 2026)
  • K200916 — Patient Administration Set (September 1, 2020)
  • K953513 — XENON CIRCUIT (November 3, 1995)
  • K952223 — XENON GAS BREATHING CIRCUIT (August 11, 1995)
  • K914747 — XENON CIRCUIT (February 27, 1992)
  • K913416 — TETLEY PATIENT ADMINISTRATION SET (October 28, 1991)
  • K912626 — BOLUS XENON CIRCUIT (August 2, 1991)
  • K904684 — AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATION (January 14, 1991)
  • K903805 — AMICI XENON ADMINISTRATION SET (January 14, 1991)
  • K903694 — AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE (October 3, 1990)

FDA data resources