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510(k) K920842

AEROSOL DELIVERY SYSTEMS by Hospitak, Inc. — Product Code LRD

K920842 is an FDA 510(k) premarket notification submitted by Hospitak, Inc. for the device "AEROSOL DELIVERY SYSTEMS". The FDA issued a decision of Substantially Equivalent on May 15, 1992. The device falls under product code LRD (Applicator, Ent Drug), a Class I device regulated under 21 CFR 874.5220. Hospitak, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1992
Date Received
February 24, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Applicator, Ent Drug
Device Class
Class I
Regulation Number
874.5220
Review Panel
EN
Submission Type

Other clearances by Hospitak, Inc.

  • K955483 — TRACH MASK MODEL (245, 246) (February 28, 1996)
  • K954787 — ILLUMINATOR (January 31, 1996)
  • K953620 — WARM N WET HMEF W/LUER ADAPTER (August 25, 1995)
  • K953619 — WARM N WET HME W/LUER ADAPTER (August 25, 1995)
  • K915750 — DISPOSABLE BACTERIAL BREATHNG FILTER (November 30, 1994)
  • K915228 — DISPOSABLE CO2 GAS SAMPLING/OXYGEN DELIVERY CANNUL (February 11, 1992)
  • K873286 — DISPOSABLE, MANUAL PULMONARY RESUSCITATOR (October 26, 1987)
  • K853600 — INFLATABLE AIR SPLINTS (September 19, 1985)
  • K844328 — OXYGEN CONCENTRATOR (December 4, 1984)
  • K843212 — LOW PRESSURE ALARM FOR OXYGEN CYLINDER (September 19, 1984)

Other clearances for product code LRD

  • K984345 — AROMAPATCH (March 19, 1999)
  • K932522 — AMSCO STERILE RECOVERIES SURGICAL PACKS (September 9, 1994)
  • K942789 — MISTASSIST (August 12, 1994)
  • K940133 — THE EXPANDACELL EAR PACK (May 23, 1994)
  • K925022 — SURGICAL TRAY (STERILE) (April 26, 1993)

FDA data resources