510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K083879Substantially Equivalent

Innocor Ergospirometry System (Inn00010), the Basic Innocor Including Breath-by-Breath System (Inn00400), Nibp(inn00500)

Innovision, Inc., Lake Bluff IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083879 is the FDA 510(k) clearance record for INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCLUDING BREATH-BY-BREATH SYSTEM (INN00400), NIBP(INN00500), a class II device, cleared for Innovision A/S on under FDA product code BZG (Spirometer, Diagnostic). FDA records list 10 510(k) clearances for Innovision A/S, from to . As of , FDA records show no recalls naming K083879.

Clearance record

Decision date
Received
(56 days to decision)
Product code
BZG Spirometer, Diagnostic
Regulation
21 CFR 868.1840
Device class
Class II
Review panel
Anesthesiology
Applicant
Innovision A/S 10 E Scranton Ave., Suite 201, Lake Bluff IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BZG

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