510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K864911Substantially Equivalent

Exersystem(tm) Mmc 5000

Med Science, St. Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864911 is the FDA 510(k) clearance record for EXERSYSTEM(TM) MMC 5000, a class II device, cleared for Med Science on under FDA product code BZM (Calculator, Pulmonary Function Interpretor (Diagnostic)). FDA records list 2 510(k) clearances for Med Science, from to . As of , FDA records show no recalls naming K864911.

Clearance record

Decision date
Received
(249 days to decision)
Product code
BZM Calculator, Pulmonary Function Interpretor (Diagnostic)
Regulation
21 CFR 868.1900
Device class
Class II
Review panel
Anesthesiology
Applicant
Med Science 1455 Page Industrial Blvd., St. Louis MO
Third party review
No

Clearances, product code BZM

Trailing 12 months

FDA records hold no clearances under product code BZM in the trailing twelve months.

FDA records show no clearances under product code BZM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BZM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260