510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K070858Substantially Equivalent

Express Series

Medical Graphics Corp., St. Paul MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070858 is the FDA 510(k) clearance record for EXPRESS SERIES, a class II device, cleared for Medical Graphics Corp. on under FDA product code BZL (Computer, Oxygen-Uptake). FDA records list 25 510(k) clearances for Medical Graphics Corp., from to . As of , FDA records show no recalls naming K070858.

Clearance record

Decision date
Received
(19 days to decision)
Product code
BZL Computer, Oxygen-Uptake
Regulation
21 CFR 868.1730
Device class
Class II
Review panel
Anesthesiology
Applicant
Medical Graphics Corp. 350 Oak Grove Pkwy., St. Paul MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BZL

Trailing 12 months

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

FDA records show no clearances under product code BZL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BZL, 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