510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K102047Substantially Equivalent

Lci Option for Innocor

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

K102047 is the FDA 510(k) clearance record for LCI OPTION FOR INNOCOR, a class II device, cleared for Innovision A/S on under FDA product code BZC (Calculator, Pulmonary Function Data). FDA records list 10 510(k) clearances for Innovision A/S, from to . As of , FDA records show one recall naming K102047.

Clearance record

Decision date
Received
(468 days to decision)
Product code
BZC Calculator, Pulmonary Function Data
Regulation
21 CFR 868.1880
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 BZC

Trailing 12 months

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

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