510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K770245Substantially Equivalent

Abdominal Fetal ECG Module

Mennen Greatbatch Electonics, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K770245 is the FDA 510(k) clearance record for ABDOMINAL FETAL ECG MODULE, a class II device, cleared for Mennen Greatbatch Electonics on under FDA product code KXN (Monitor, Cardiac, Fetal). FDA records list 6 510(k) clearances for Mennen Greatbatch Electonics, from to . As of , FDA records show no recalls naming K770245.

Clearance record

Decision date
Received
(7 days to decision)
Product code
KXN Monitor, Cardiac, Fetal
Regulation
21 CFR 884.2600
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Mennen Greatbatch Electonics 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KXN

Trailing 12 months

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

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