SPIROLOOP— 510(k) K841858

Substantially Equivalent

Datamed, Inc.

FDA 510(k) clearance K841858 for SPIROLOOP, Substantially Equivalent on 1984-07-11. Applicant: Datamed, Inc.. Device class: 2.

Clearance details

Applicant: Datamed, Inc.
Product code: Code BSE
Device class: Class 2
Regulation: 21 CFR 868.1640
Advisory panel: Anesthesiology
Date received: 1984-05-04
Decision date: 1984-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BSE

K903939 — PANDA HELIUM GAS ANALYZER1991-01-03
K843843 — HE TEST1984-12-04

More clearances from Datamed, Inc.

K904966 — DATAMED MODEL 401A TRANSRECIEVER1991-07-18
K811419 — SPRIO-LOOP1981-06-12

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