510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K832356Substantially Equivalent

Portable Operat. Rm. Monitors Hs30/40

Medtel Pty., Ltd., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K832356 is the FDA 510(k) clearance record for PORTABLE OPERAT. RM. MONITORS HS30/40, a class I device, cleared for Medtel Pty. , Ltd. on under FDA product code BZN (Cart, Emergency, Cardiopulmonary (Excluding Equipment)). FDA records list 8 510(k) clearances for Medtel Pty. , Ltd., from to . As of , FDA records show no recalls naming K832356.

Clearance record

Decision date
Received
(102 days to decision)
Product code
BZN Cart, Emergency, Cardiopulmonary (Excluding Equipment)
Regulation
21 CFR 868.6175
Device class
Class I
Review panel
Anesthesiology
Applicant
Medtel Pty. , Ltd. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code BZN

Trailing 12 months

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

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