510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K832005Substantially Equivalent

Jp-2 Respiratory Monitoring System

Morgan Associates, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K832005 is the FDA 510(k) clearance record for JP-2 RESPIRATORY MONITORING SYSTEM, a class II device, cleared for Morgan Associates, Inc. on under FDA product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase). FDA records list 2 510(k) clearances for Morgan Associates, Inc., from to . As of , FDA records show no recalls naming K832005.

Clearance record

Decision date
Received
(189 days to decision)
Product code
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Regulation
21 CFR 868.1400
Device class
Class II
Review panel
Anesthesiology
Applicant
Morgan Associates, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code CCK

Trailing 12 months
3 clearances under product code CCK in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CCK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20261
August 20261
September 20260
October 20260