JAYCO HYDROGEN MONITOR— 510(k) K882499

Substantially Equivalent

Enteron, Inc.

FDA 510(k) clearance K882499 for JAYCO HYDROGEN MONITOR, Substantially Equivalent on 1988-06-28. Applicant: Enteron, Inc.. Device class: 1.

Clearance details

Applicant: Enteron, Inc.
Product code: Code NRH
Device class: Class 1
Regulation: 21 CFR 862.1820
Advisory panel: Clinical Chemistry
Date received: 1988-06-17
Decision date: 1988-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Camp Hill, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NRH

K033688 — MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY2004-05-19
K963376 — MICRO H21997-01-24
K874892 — VITALOGRAPH-EC60 HYDROGEN MONITOR1988-06-02

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