ABDOMINAL FETAL ECG MODULE— 510(k) K770245

Name: FDA 510(k) clearance K770245
Creator: U.S. Food and Drug Administration
Published: 1977-02-14

Substantially Equivalent

Mennen Greatbatch Electonics

FDA 510(k) clearance K770245 for ABDOMINAL FETAL ECG MODULE, Substantially Equivalent on 1977-02-14. Applicant: Mennen Greatbatch Electonics. Device class: 2.

Clearance details

Applicant: Mennen Greatbatch Electonics
Product code: Code KXN
Device class: Class 2
Regulation: 21 CFR 884.2600
Advisory panel: Obstetrics/Gynecology
Date received: 1977-02-07
Decision date: 1977-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KXN

view all

K760968 — CENTRAL STATION REPEATER (MODEL 8032A)1976-12-17

More clearances from Mennen Greatbatch Electonics

view all

K772000 — ECG TELEMETRY SYSTEM1977-11-22
K770832 — PORTASCOPE II1977-06-03
K770279 — MONITOR, PORTABLE, PART #431-0101977-02-24
K770246 — ISOLATED EEG AMPLIFIER MODULE1977-02-14
K770247 — D.C. AMPLIFIER MODULE1977-02-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.