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510(k) K893532

RESUBMITTED RADIOAEROSOL CONT. SYSTEM MP-963 by Medipart Jerry Alexander — Product Code CBN

K893532 is an FDA 510(k) premarket notification submitted by Medipart Jerry Alexander for the device "RESUBMITTED RADIOAEROSOL CONT. SYSTEM MP-963". The FDA issued a decision of Substantially Equivalent on August 21, 1989. The device falls under product code CBN (Apparatus, Gas-Scavenging), a Class II device regulated under 21 CFR 868.5430. Medipart Jerry Alexander has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1989
Date Received
May 8, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Gas-Scavenging
Device Class
Class II
Regulation Number
868.5430
Review Panel
AN
Submission Type

Other clearances by Medipart Jerry Alexander

  • K896885 — DISPOSABLE RESPIRTORY KIT (MP-200) (February 26, 1990)
  • K896125 — MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133M (February 1, 1990)
  • K896476 — DISP. RADIOAEROSOL KIT (MP-400-M) TO FIT SHIELD (January 22, 1990)
  • K896124 — MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133 (January 22, 1990)
  • K896475 — DISP. RADIOAEROSOL KIT (MP-400) TO FIT LEAD SHIELD (January 22, 1990)
  • K894138 — MEDIPART DISPOSABLE AEROSOL SYSTEM MP-070-PTD (September 26, 1989)
  • K862783 — MP-XMV DISPOSABLE FACE MASK (August 1, 1986)
  • K862794 — MP-070 RADIOAEROSOL KIT (August 1, 1986)
  • K862795 — MP-070-M RADIOAEROSOL KIT (August 1, 1986)
  • K862782 — MP-XML DISPOSABLE FACE MASK (August 1, 1986)

Other clearances for product code CBN

  • K223452 — Nitronox Scavenger Plus (March 5, 2023)
  • K193646 — Dynamic Gas Scavenging System 2 (DGSS - 2) (December 4, 2020)
  • K160950 — MINISCAV (May 5, 2017)
  • K142138 — ISO-GARD MASK (October 30, 2014)
  • K132729 — ISO-GARD MASK (January 9, 2014)
  • K123176 — ISO-GARD CLEARAIR MASK (February 14, 2013)
  • K110930 — ACTIVE WASTE GAS SCAVENGER (June 23, 2011)
  • K092031 — VAPOR-CLEAR, MODEL 100 (April 16, 2010)
  • K080039 — PASSIVE WASTE GAS SCAVENGER, MODEL 14600 (April 14, 2008)
  • K072255 — MINRAD INC. NASAL SCAVENGING CIRCUIT (October 18, 2007)

FDA data resources